HOMECHOICE AUTOMATED PD SET WITH CASSETTE

Report

Report Number: 1416980-2012-06299
Event Type: Injury
Date Received: December 3, 2012
Date of Event: October 1, 2012
Report Date: November 9, 2012
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
PMA / PMN Number: K923065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12E15011 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

Additional Manufacturer Narrative · 1

(B)(4). FOLLOW UP WAS RECEIVED FROM A NURSE. IT WAS REPORTED THAT IN SEPTEMBER, THE PATIENT EXPERIENCED AN ABSCESS ON THEIR BUTTOCKS AND WAS TREATED WITH ORAL BACTRIM TWICE DAILY FOR THE EVENT. ON A LATER DATE, THE PATIENT EXPERIENCED AN ARTERIOVENOUS (AV) FISTULA SITE INFECTION ON THEIR RIGHT ARM (PREVIOUSLY REPORTED AS CELLULITIS ON RIGHT ARM). THE PATIENT WAS TREATED WITH IV VANCOMYCIN, 1 GRAM TWICE A WEEK FOR 2 WEEKS, FOR THE AV FISTULA SITE INFECTION ON THEIR RIGHT ARM. ELEVEN DAYS LATER, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT, AND WAS HOSPITALIZED. THE CAUSE OF THE BACTERIAL PERITONITIS WAS TOUCH CONTAMINATION (DETAILS AND DATE NOT REPORTED). ON THE SAME DAY, THE PATIENT RECEIVED A ONE TIME DOSE OF PIPERACILLIN, 2.25 GRAM, IV, AS A TREATMENT FOR BACTERIAL PERITONITIS. ON THAT SAME DAY, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN, 1 GRAM, INTRA-PERITONEALLY (IP), EVERY THIRD DAY, FORTAZ, 2 GRAM, IP, DAILY, AND CIPRO, 500 MILLIGRAM, ORAL, TWICE DAILY, FOR THE BACTERIAL PERITONITIS. FIVE DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THREE DAYS AFTER DISCHARGE, THE PATIENT WAS DIAGNOSED WITH FUNGAL PERITONITIS. THE CAUSE OF THE FUNGAL PERITONITIS WAS UNKNOWN BUT BELIEVED TO BE CAUSED BY CHRONIC ANTIBIOTIC USE. FOUR DAYS LATER, THE PATIENT'S PD CATHETER WAS REMOVED AND HEMODIALYSIS THERAPY WAS INITIATED. ON THAT SAME DAY, THE PATIENT BEGAN TREATMENT WITH ORAL FLUCONAZOLE, 200 MILLIGRAM DAILY, (PREVIOUSLY DESCRIBED AS DIFLUCAN) FOR THE FUNGAL PERITONITIS. THE PATIENT WAS NOT RETRAINED ON PROPER ASEPTIC TECHNIQUE AS THE PATIENT WAS NO LONGER UTILIZING PD THERAPY. THE PATIENT RECOVERED FROM THE EVENTS OF AV FISTULA SITE INFECTION, ABSCESS ON THEIR BUTTOCKS, BACTERIAL PERITONITIS, AND FUNGAL PERITONITIS.

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A NURSE IN THE USA OF FISTULA COMPLICATION, SKIN TEAR FROM THE SURGICAL STERI STRIP, CELLULITIS ON RIGHT ARM, PERITONITIS WITH CULTURE POSITIVE FOR SERRATIA AND PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA UNKNOWN IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD A FISTULA COMPLICATION FURTHER DESCRIBED AS THE FISTULA WAS IN TOO DEEP AND NEEDED TO BE RAISED UP. ON (B)(6) 2012, THE PATIENT HAD A FISTULA SURGERY ON THE RIGHT ARM. ON (B)(6) 2012, THE PATIENT DEVELOPED CELLULITIS ON THE RIGHT ARM DUE TO A SKIN TEAR FROM A SURGICAL STERI STRIP. THE PATIENT WAS TREATED WITH VANCOMYCIN 1G TWICE A WEEK FOR TWO WEEKS. ON (B)(6) 2012, THE PATIENT RECOVERED FROM CELLULITIS. ON THAT SAME DAY, THE PATIENT DEVELOPED SERRATIA PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH PIPERACILLIN AND FORTAZ FOR THE PERITONITIS. ON AN UNKNOWN DATE, PIPERACILLIN AND FORTAZ WERE DISCONTINUED AND THE PATIENT WAS STARTED ON CIPRO ORALLY. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED. ON (B)(6) 2012, A PERITONEAL EFFLUENT CULTURE PERFORMED WAS NEGATIVE FOR SERRATIA, BUT SHOWED UNKNOWN CANDIDA. THE CAUSE FOR SERRATIA PERITONITIS AND CANDIDA UNKNOWN PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH DIFLUCAN. ON (B)(6) 2012, THE PD CATHETER WAS REMOVED. ON (B)(6) 2012, THE PATIENT WAS STARTED ON HEMODIALYSIS THERAPY. AT THE TIME OF THIS REPORT, HEMODIALYSIS WAS ONGOING. ON AN UNREPORTED DATE, THE PATIENT RECOVERED SERRATIA PERITONITIS. THE OUTCOME OF THE FISTULA COMPLICATION AND SKIN TEAR FROM THE SURGICAL STERI STRIP WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THE EVENT OF CANDIDA UNKNOWN PERITONITIS. PER THE NURSE, THE EVENTS WERE UNRELATED TO DIANEAL THERAPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Hospitalization\| R	DIANEAL PD4 AMBUFLEX\| EXTRANEAL VIAFLEX\| HOMECHOICE