Description of Event or Problem · 1
PT IS ON PERITONEAL DIALYSIS - PD AND WAS USING FRESENIUS LIBERTY CYCLER WHEN THIS EVENT OCCURRED. PT CONTRACTED MULTI-ORGANISM PERITONITIS, BEGINNING WITH CLOUDY DIALYSIS EFFLUENT ON (B)(6) 2012. THE ORGANISMS WERE IDENTIFIED VIA DIALYSIS EFFLUENT CULTURE TO BE E COLI, CITROBACTER BRAAKII, AND TWO ANAEROBES NOT FURTHER IDENTIFIED. DIALYSIS CENTER ATTEMPTED TO TREAT PERITONITIS OUTPATIENT FOR A MONTH WITH INTRAPERITONEAL CEFTAZIDIME, FOLLOWED BY INTRAPERITONEAL GENTAMICIN AND ORAL CIPROFLOXACIN AND RIFAMPIN. DIALYSIS EFFLUENT WOULD CLEAR, AND THEN THE INFECTION WOULD REPEATEDLY RECUR. ON (B)(6) 2012, PT WENT TO HOSP ER WITH SEVERE ABDOMINAL PAIN, DIARRHEA, VOMITING AND FEVER. PT WAS IN HOSP FOR 6 DAYS WITH LIFE-THREATENING PERITONITIS. PD CATHETER HAD TO BE REMOVED BECAUSE IT WAS THOUGHT THAT THE BACTERIA HAD FORMED A BIOFILM ON IT, AND PT HAD TO BE STARTED ON EMERGENCY HEMODIALYSIS - HEMO. PERITONITIS WAS TREATED WITH IV GENTAMICIN AND LEVAQUIN IN HOSP, AND PT WAS SENT HOME WITH ORAL LEVAQUIN 10 D AND METRONIDAZOLE 14 D. PT HAD TO BE ON IN-CENTER HEMODIALYSIS - HEMO FOR 4 MONTHS (B)(6) 2012, TO ALLOW GI TRACT/PERITONEUM TO HEAL AND TO HAVE NEW PD CATHETER PLACED. AS PT HAS LOW BODY MASS AND STILL PRODUCES > 1 L OF URINE PER DAY, HEMO WAS EXTREMELY TRAUMATIC AND CAUSED HER TO LOSE TOO MUCH FLUID AND HAVE DANGEROUSLY LOW BLOOD PRESSURE DURING TREATMENTS. SHE FELT ILL AND WEAK THE ENTIRE 4 MONTHS SHE WAS ON CHEMO AND DID NOT HAVE ANY QUALITY OF LIFE UNTIL SHE WAS ABLE TO RETURN TO PD ON (B)(6 )2012. PT HAD AN ABDOMINAL CT SCAN ON (B)(6) 2012, BUT IT DID NOT SHOW ANY PROBLEMS WITH THE GI TRACT THAT COULD HAVE EXPLAINED THE GRAM-NEGATIVE/ANAEROBE PERITONITIS. FOR EXAMPLE, THERE WAS NO INDICATION OF DIVERTICULITIS THE PT HAS HAD DIVERTICULITIS FOR MANY YRS WITHOUT ANY SYMPTOMS, BOWEL OBSTRUCTION, OR PD CATHETER PROBLEMS. THE CAUSE OF THE PERITONITIS HAS REMAINED A MYSTERY UNTIL NOW. FRESENIUS MEDICAL CARE JUST INFORMED THE PT AND HER DIALYSIS CENTER VIA A CERTIFIED LETTER DATED 06/25/2013 AND PHONE CALLS DURING THAT SAME WEEK ABOUT A VOLUNTARY RECALL OF LIBERTY CYCLER TUBING SETS OF LOT NO. 11PR08083 DUE TO A PROPENSITY FOR THESE TUBING SETS TO LEAK AND BE A POTENTIAL SOURCE OF PERITONITIS. FRESENIUS STATED THAT THESE TUBING SETS WERE MFG IN APR 2012 AND WOULD HAVE BEEN DELIVERED TO THE PT SHORTLY AFTERWARD. THE PT DID NOT DIRECTLY OBSERVE ANY LEAKING FROM TUBING SETS THAT SHE USED DURING THAT TIME, BUT IT IS POSSIBLE THAT THE LEAK WAS A PINHOLE LEAK AND ESCAPED VISUAL DETECTION. ALTHOUGH A DIRECT CONNECTION CANNOT BE MADE BETWEEN THESE TUBING SETS AND THE PT'S PERITONITIS, THE FOLLOWING FACTS INDICATE A LINK: THE TIME PERIODS OF DELIVERY OF POTENTIALLY DEFECTING TUBING SETS TO THE PT AND ONSET OF PERITONITIS COINCIDE; THE PERITONITIS WAS MULTI-ORGANISM; AND NO DEFECT COULD BE FOUND IN THE PT'S GI TRACT - VIA CT SCAN TO EXPLAIN GRAM-NEGATIVE/ANAEROBE PERITONITIS. BECAUSE IT TOOK FRESENIUS OVER A YR TO INFORM THE PT AND HER DIALYSIS CENTER ABOUT THE DEFECTIVE TUBING SETS, LONG AFTER THEY HAD BEEN USED. THE PT RECEIVED MONTHLY DELIVERIES OF DIALYSIS SUPPLIES AND USES UP ALL SUPPLIES WITHIN 5-6 WEEKS OF RECEIVING THEM. THE PT WILL BE SWITCHED TO BAXTER PD SUPPLIES. FRESENIUS SUPPLIES CAN NO LONGER BE TRUSTED, ESPECIALLY WITH SUCH DELAYED AND INADEQUATE ACTION ON THEIR PART TO INFORM PTS AND DIALYSIS CENTERS OF DEFECTIVE PRODUCTS. DOSE OR AMOUNT: 1 TUBING SET; FREQUENCY: DAILY. ROUTE: INTRAPERITONEAL. DATES OF USE: (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: PERITONEAL DIALYSIS FOR ESRD.