Description of Event or Problem · 1
INCREASED PATIENT COMPLAINTS RE: ABBOTT PERITONEAL DIALYSATE BAGS LEAKING PROMPTED AN INITIAL COMPLAINT TO ABBOTT VIA THEIR SALES REPRESENTATIVE IN LATE APRIL. AT THE TIME, WE HAD CAUTIONED OUR HOME PATIENTS TO BE EXTREMELY CAREFUL ABOUT CHECKING THESE BAGS FOR LEAKS PRIOR TO USE. A LETTER FORM ABBOTT DATED MAY 14, 1992 ASSURED US THIS PROBLEM WAS MOST LIKELY DUE TO "ROUGH HANDLING" DURING SHIPPING. ABBOTT CREATED A TASK FORCE TO LOOK INTO THE PROBLEM. ON JUNE 8, 1992, ONE OF OUR HOME DIALYSIS PATIENTS PRESENTED WITH PERITONITIS. OUR INVESTIGATION REVEALED THAT SHE HAD UNKNOWINGLY USED A BAGOF ABBOTT DIALYSATE THAT LEAKED ON JUNE 7. PATIENT HAPPENS TO BE VISUALLY IMPAIRED. HER BAGS ARE ROUTINELY CHECKED PRIOR TO USE BY A HOME HEALTH NURSE. THE BAG HAD BEEN ASSESSED AS BEING PATIENT BY THE NURSE EARLIER IN THE DAY. IMMEDIATELY PRIOR TO USE, PATIENT HAD WARMED BAG PER ROUTINE IN THE MICROWAVE. PATIENT DISCOVERED LEAK IN BAG AFTER PERFORMING EXCHANGE. PATIENT WAS TREATED WITH KEFZOL (ANTIBIOTIC) AFTER DEVELOPING A COAG. NEG. STAPH. PERITONITIS. FURTHER CONTACT WITH ABBOTT RE: THIS PROBLEM RESULTED IN A PHONE CONVERSATION WITH BOTH THE SALES REP. AND THE NATIONAL PRODUCT MANAGER RE: NOT ONLY THIS EPISODE, BUT CONTINUED REPORTS FROM 2 OTHER PATIENTS ABOUT BAGS THAT WERE LEAKING WHEN TAKEN OUT OF SHIPPING CONTAINER. ABBOTT NOTED THEY'D IDENTIFIED A "PROBLEM: EXISTED AS EARLY AS JANUARY AND THAT SEVERAL MANUFACTURING PROCESSES HAD BEEN CHANGED AS A RESULT. ADDITIONAL DEVICES INVOLVED INCL.: PERITONEAL CATHETER, OPTUM EXCHANGE DEVICE, AND PATIENT'S MICROWAVE OVEN (TYPE UNKNOWN).INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS DESTROYED/DISPOSED OF.