FLOSEAL HEMOSTATIC MATRIX
Report
- Report Number
- 2954761-2011-00027
- Event Type
- Injury
- Date Received
- April 27, 2011
- Report Date
- April 5, 2011
- Manufacturer
- BAXTER HEALTHCARE - HAYWARD
- Product Code
- LMF
- PMA / PMN Number
- P990009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). BAXTER MEDICAL ASSESSMENT: THE FINDING OF THE EXTERNAL EXPERT ORTHOPEDIC SURGEON POINT TOWARD A MISUSE OF FLOSEAL BY THIS DEPARTMENT, SPECIFICALLY A LACK OF IRRIGATION TO REMOVE ANY EXCESS FLOSEAL MATRIX FROM THE JOINT PRIOR TO CLOSURE. NO SPECIFIC DETAILS ON PRODUCT APPLICATION ARE FORTHCOMING; THEREFORE, IT CAN'T BE CONFIRMED IF THIS WAS THE CASE. IT IS, HOWEVER, WELL KNOWN THAT EXCESS MATRIX LEFT IN SITU CAN CONTRIBUTE TO FOREIGN BODY REACTION, SUCH AS TISSUE IRRITATION AND INFLAMMATION. THE INSTRUCTIONS FOR USE CLEARLY EMPHASIZE THE NEED FOR METICULOUS IRRIGATION IN ANY AREA OF BONY CONFINE WHICH DESCRIBES THE KNEE JOINT WELL. LARGE UNINCORPORATED AMOUNTS OF GELATIN MATRIX COULD, AT LEAST THEORETICALLY ACT AS A FOOD SOURCE IF BACTERIA WERE INTRODUCED INTO THE JOINT DURING SURGERY. THIS IS HOWEVER A SINGLE CENTER WHICH REQUIRED AN OUTSIDE EXPERT TO COME IN AND EVALUATE THEIR SURGICAL TECHNIQUE; IT IS THEREFORE REASONABLE TO BELIEVE THAT FLOSEAL WAS NOT THE ROOT CAUSE OF THE BACTERIAL INFECTIONS, BUT A FOOD SOURCE TO SUPPORT THEIR GROWTH DUE TO INAPPROPRIATE LACK OF IRRIGATION OF THE PRODUCT. AS THE INSTITUTION HAS NO INTENTION OF ALLOWING THE USE OF FLOSEAL TO RESUME, THERE IS NO POTENTIAL FOR CONTINUED MISUSE OF FLOSEAL. IF HOWEVER, THE INSTITUTE DOES PERMIT ITS USE IN THE FUTURE, DOCUMENTED RETRAINING OF THE ORTHOPEDIC SURGEONS WOULD BE REQUIRED. THERE IS NO DEFICIENCY IN THE CURRENT INSTRUCTIONS FOR USE. (B)(4). THE HOSPITAL SITE HAS DISCONTINUED THE USE OF FLOSEAL IN TKA PROCEDURES. THE HOSPITAL SITE WILL BE ADVISED TO CONTACT BAXTER FOR RETRAINING ON PROPER APPLICATION TECHNIQUE IF THEY RESUME THE USE OF FLOSEAL IN FUTURE TKA PROCEDURES. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.
PATIENT 11: THE BAXTER LOCAL SALES REPRESENTATIVE WAS INFORMED BY ONE OF THE ORTHOPEDIC SURGEONS AT (B)(6) MEDICAL CENTER THAT THE ORTHOPEDIC DEPARTMENT WAS INSTRUCTED TO STOP USING FLOSEAL DURING TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURES. THE SURGEON STATED THAT THIS DIRECTIVE CAME AFTER A PATIENT ACQUIRED A POST OPERATIVE WOUND INFECTION FOLLOWING TKA WITH THE USE OF FLOSEAL. ADDITIONAL INFORMATION RECEIVED FROM INFECTION CONTROL NURSE AT HOSPITAL SITE ON 08-APR-2011: THE INFECTION CONTROL NURSE ACKNOWLEDGED THAT THEY HAD A SERIES OF POST OPERATIVE WOUND INFECTIONS, BUT WOULD NOT CONFIRM THE NUMBER OF EXACT CASES. THE INFECTION CONTROL DEPARTMENT HIRED AN EXTERNAL 3RD PARTY EXPERT TO ADVISE THEM ON HOW TO PROCEED. ONE OF SEVERAL SUGGESTED STEPS WAS TO DISCONTINUE THE USE OF FLOSEAL IN TKA PROCEDURES, ALTHOUGH THEY CONTINUE TO USE FLOSEAL IN OTHER PROCEDURES. NO FURTHER INFORMATION IS FORTHCOMING FROM USER FACILITY. ADDITIONAL INFORMATION FROM RISK MANAGER AT HOSPITAL SITE ON 21-APR-2011: THE RISK MANAGER EXPLAINED THAT THE EXPERT CONSULTANT THEY HIRED TO ASSESS THE SITUATION WAS AN ORTHOPEDIC SURGEON HIMSELF. IN HIS OBSERVATION OF THEIR SURGICAL PRACTICE HE NOTED THAT FLOSEAL WAS BEING USED INAPPROPRIATELY AND TAUGHT THE SURGEONS ALTERNATIVE WAYS TO OBTAIN HEMOSTASIS DURING TKA. HE BELIEVED THAT THEIR USE OF FLOSEAL INTRODUCED A LARGE AMOUNT OF FOREIGN MATERIAL IN THE JOINT AND ACTED AS A NIDUS FOR INFECTION. THEREFORE THEIR USE OF FLOSEAL HAS BEEN STOPPED PERMANENTLY. PLEASE KNOW THAT THIS IS ONE OF TWELVE FLOSEAL CASES REPORTED FROM (B)(6) MEDICAL CENTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOSEAL HEMOSTATIC MATRIX | AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED | LMF | BAXTER HEALTHCARE - HAYWARD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |