FDA recall Cardioplegia solution

[windsurfer]

Check out:
http://www.fda.gov/opacom/7alerts.html
Bob
Recall: Injectable Products made by Central Admixture Pharmacy Service (CAPS) (September 17, 2005)

Injectable Products made by Central Admixture Pharmacy Service (CAPS) of Lanham, Maryland
Audience: Audience - Hospital Risk Managers, Pharmacists and Nursing Supervisory Staff
FDA is notifying healthcare professionals and hospitals about a product recall involving all injectable products manufactured by Central Admixture Pharmacy Services, Inc. of Lanham, Maryland (CAPS) due to concerns regarding the sterility of these injectable products. CAPS distributed the affected injectable products to hospitals in Maryland, Delaware, Washington, D.C., and Virginia. Gram negative rods have been identified in two lots of Cardioplegia solution manufactured by CAPS. Non-sterility of injectable products could represent a serious hazard to health that could lead to life-threatening injuries and death.

The following products distributed up to September 16, 2005, are affected by this action:


* Cardioplegia solutions including: Cardioplegia, Cold Cardioplegia, Warm Cardioplegia, Blood Cardioplegia 1, Blood Cardioplegia 2, Cardioplegia Base 1, Cardioplegia Base 2, Cardioplegia Base, Cardioplegia Reperfusion, Cardioplegia High Potassium, Cardioplegia Low Potassium, Cardioplegia #1, Cardioplegia #2 Cardioplegia #3; Maintenance Cardioplegia, Enriched Cardioplegia, Cardioplegia Hot Shot, Cardioplegia Base Enriched
* Oxytocin injectable products including: Oxytocin Infusion, Oxytocin 20 units, Oxytocin 30 units, Oxytocin D5 ½ NS, Oxytocin in Lactated Ringers
* Promethazine
* Magnesium-containing injectable products including: Magnesium 1 GM, Magnesium 2 GM, Magnesium Sulfate 2 GM, Magnesium 4 GM, Hydration-Magnesium in D5W, Magnesium Infusion, Magnesium in Lactated Ringers
* Heparin Replacement
* Antibiotic Irrigation Bag and Bottle
* Bupivicaine 0.25 % and 0.5%, Pain Bags (Bupivicaine 0.25 %)
* Dialysate solutions including: Citrate Dialysate, Heparin Dialysate, Pediatric Dialysate, Hydration Dialysate #1, Hydration Dialysate #2, CRRT Dialysate, CVVHD (Dialysate) 300, CVVHD (Dialysate) 342, CVVHD Pediatric Formula (Normocarb), CVVHD Formalin #1, CVVHD Formalin #2, CVVHD Formalin #3, CVVHD Non-Standard, CVVHD D5W, CVVHD ½ NS, CVVHD NS
* Total Parenteral Nutrition (TPN) products including: TPN-Day, TPN-Day 1 Neonatal Stock Solution
* Diltiazem (Cardizem)
* Norepinephrine (Levophed)
* Cefazolin

Although CAPS has directly notified known hospital customers of the recall, hospitals, physicians, and health care workers are urged to examine their supplies for any CAPS of Lanham, MD injectable products and immediately discontinue their use and quarantine the products.

[September 17, 2005 - Recall Notice - CAPS of Lanham, MD]

 

[Nancy]

Thank you for posting this. Joe just got out of the hospital for several things. One of them was a bloodstream infection with Klebsiella bacteria, which is a gram negative bacteria. There are at least two products on that list that might have been the culprits.

There seemed to be no direct cause of his infection within his own body, and he did develop it in the hospital, and it was a sudden onset. It coincided with his splenic infarctions, but doesn't seem related. Up to now the infection has been a mystery.

Now it has me wondering.

Klebsiella bacteria can be a killer, especially when it gets into the bloodstream or lungs. Fortunately his doctors got on it right away, and it didn't get into Joe's lungs, and he did get a pneumonia vac. while there, even though he had had one recently.

 

[gijanet]

Uhhhhhhhhh, so could someone interpet?

Uhhhhhhhhh, so could someone interpet?

Course Katie had surgery July 12th - two actually, and was hospitalized for almost a month. She, of course, had TPN and a heparin replacement drug and no telling what else on this list. Would this still pose a threat one to two months later, or are we in the clear now? I would think the latter, but any thoughts are appreciated. If I wanted to find out what all Katie had, what department would I start with? Wonder if this could have been responsible for Katie's mysterious "growth" resulting in an IV antibiotic cocktail regimen or if her culture was truly contaminated as Dr. Bove suspected. Thanks and hugs. Janet

 

[Nancy]

I noticed that this problem was only for a few states, and the hospitals were identified--However--

Like other stories along the same lines, it may be found out later that this included more than originally thought.

I believe that if you request information about the exact culture results of your daughter, you are entitled to that information.

My guess is that most all hospitals will be on high alert for disgruntled patients and will protect their own arses. I'm quite sure they will be in big time denial mode.

The manufacturer's information did not specify which bacteria was the contaminant, only that it was gram negative. There are many gram negative bacteria.

 

[geebee]

Distribution areas only mean that is where the manufacturer shipped the products. It may not take into consideration where the distributor sends the product once it receives it. That means these products could be anywhere.

Nancy, I think there could be a good chance this may be where Joe got his "source unknown" infection. I would do some really in-depth research into the products he received.

Janet, same with you. Ask for detailed chart information. All the products given to a patient are listed on charts as to type, lot number, etc. However, unless Katie is having problems with infection now, she is probably OK. BUT - I am not a doctor and this is just my opinion.

 

[Nancy]

Apparently endocarditis can remain a fear even after antibiotics have worked. Don't quite understand that, but will keep it in the back of my mind.

Joe is having a 6 week course of Cipro, since he can't have cephalosporins.

I will be writing to the hospital about this among other things.

Suddenly, while on several IVs, they were all removed and pills substituted, so I am highly suspicious.

These included Heparin, antibiotics and Cardizem, all on the recall list.

 

[windsurfer]

surgery resumed

surgery resumed

Surgery has resumed at the hospital where they found the contaminated fluids because they are convinced the problem has been identified. No evidence yet that any other of the 46 hospitals had a problem. See http://fredericksburg.com/News/FLS/2005/092005/09232005/131894 for more details.
Bob

 

[windsurfer]

Surgical problem widens

Surgical problem widens

Another hospital, this one in MD, may have had a problem with contaminated cardioplegia solution according to reports yet it remains unnamed.
"Due to state confidentiality requirements, we cannot disclose whether an investigation is in process," ,...
http://fredericksburg.com/News/FLS/2005/092005/09282005/133125
So far there has been no news as to whether other bags of solution from other hospitals were contaminated - yet one would think that would be the first thing the FDA and CDC would look into after all the bags were quarantined in the 46 other hospitals in VA, MD and WDC. The secrecy may have to do with the legal and economic impact on both the manufacturer and its customers. This way other hospitals' reputations are preserved, business continues as normal yet no patients are effected since the suspect solutions have been quarantined.

Bob

 

[windsurfer]

mystery continues

mystery continues

See latest article on the mystery of what caused the contaminated heart-surgery solution at:
http://fredericksburg.com/News/FLS/2005/092005/09292005/132803

In essence, if true that neither the FDA nor the manufacturer found contaminated bags at any other of the 46 hospitals then how could there be contamination at just one location when the contaminated bags were sealed. And if a random event with low probability, then how come it happened (as believed by the hospital) at two other times earlier in the year, January and June - assuming solutions are ordered for only a few weeks supply at a time. Could it have something to do with local distribution and storage e.g. not kept refrigerated so bacteria multiplied to dangerous levels or other ports on sealed bags were tampered with,... I hope the FDA or manufacturer will let us know the source of the problem or speculation will continue e.g. - are the ingredients used by the manufacturer contaminated so the problem is further upstream and therefore those making their own mixture continue the risk. The mystery continues,..

Bob

 

[Nancy]

If the bags were contaminated with gram negative bacteria, then why weren't the patients diagnosed as having bacteremia or a gram negative bacterial infection, instead of severe inflammatory response syndrone. That has me puzzled.

They seem like two different things, and like comparing oranges to apples.

I, of the very jaded mind, am thinking that there is a large amount of obfuscation going on due to the possibility of lawyer involvement. Lots of tap dancing around the elephant in the living room.

Oh dear, slap, slap, shouldn't be thinking like that.

 

[windsurfer]

legal versus health issues

legal versus health issues

If the bags were contaminated with gram negative bacteria, then why weren't the patients diagnosed as having bacteremia or a gram negative bacterial infection, instead of severe inflammatory response syndrone. That has me puzzled.,...

Good point, Nancy. If SIRS is something that everyone gets from the H/L machine - just some get it worse, then that is a very different scenario than gram negative bacteria in the IV solution as far as what one can do about it e.g. find/stop the source of the contamination.

Of course, the legal issues may cloud how much we find out, which is a shame since it makes our job of deciding where to go that much more difficult. Perhaps surgery patient prospects should sign non-disclosures so that they can benefit without the hospital's outcome data putting them at the mercy of the ambulance chasers.

Right now it is very difficult to get such data from surgeons and I can see why. There needs to be a mechanism that both benefits patients and protects the health infrastructure from lawsuits or from losing patients when it is not justified. When it is justified, exposure is good since it leads to corrective action and therefore the ultimate survival of the local heart center.

Bob