HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

Report

Report Number: 1416980-2013-03325
Event Type: Death
Date Received: February 8, 2013
Date of Event: December 1, 2012
Report Date: January 17, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K012988
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE OFFICIAL CAUSE OF DEATH LISTED ON THE PATIENT'S DEATH CERTIFICATE WAS AS FOLLOWS: HYPERKALEMIA WITH 4 DAYS ONSET TO DEATH, CHRONIC RENAL FAILURE WITH 10 MONTHS ONSET TO DEATH, BILATERAL WILM'S TUMOR WITH 19 MONTHS ONSET TO DEATH, AND GENETIC OVERGROWTH SYNDROME WITH 2 YEARS ONSET TO DEATH. A SIGNIFICANT CONTRIBUTING FACTOR, BUT NOT CAUSE OF DEATH, WAS RECURRENT PERITONITIS.

Additional Manufacturer Narrative · 1

(B)(4). THIS IS REPORT 1 OF 2. A SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE NO SAMPLE WAS RETURNED TO BAXTER, THE REVIEW OF MANUFACTURING RECORDS FOR POTENTIALLY ASSOCIATED LOTS H12J02051,H12I08018, AND H12H01080 REVEALED NO ISSUES OR DEVIATIONS FROM STANDARD PROCEDURE, AND THERE WERE NO TYPES OF USE ERRORS OR OTHER DEVICE MALFUNCTIONS THAT MIGHT HAVE CAUSED THE REPORTED ISSUE.

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM A NURSE AND SOCIAL WORKER OF PERITONITIS AND DEATH IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. A NURSE CONTACTED BAXTER CUSTOMER SERVICES AND REPORTED THAT THE PATIENT HAD DIED. HOWEVER, THE CAUSE OF DEATH WAS UNKNOWN. DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. THE SOCIAL WORKER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION, WHICH WAS FROM THE PATIENT'S HOSPITAL MEDICAL RECORD. ON AN UNKNOWN DATE, THE PATIENT BEGAN AUTOMATED PERITONEAL DIALYSIS THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS DIAGNOSED WITH RECURRENT PERITONITIS, HOWEVER THE TREATMENT WAS NOT REPORTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED CLOUDY PERITONEAL EFFLUENT AND A FEW DAYS LATER THE PATIENT WAS HOSPITALIZED FOR PERITONITIS (ONSET DATE OF PERITONITIS WAS UNKNOWN). THE PATIENT WAS TREATED FOR PERITONITIS WITH 400MG OF VANCOMYCIN INTRAVENOUSLY (IV) (FREQUENCY UNKNOWN) AND ZOSIN (ROUTE, DOSE, AND FREQUENCY UNKNOWN). THE NEXT DAY, PD THERAPY WAS DISCONTINUED AND THE PD CATHETER WAS REMOVED. THE PATIENT BEGAN HEMODIALYSIS (HD) ON THE SAME DAY. THREE WEEKS LATER A DO NOT RESUSCITATE ORDER WAS SIGNED AND HD WAS DISCONTINUED. THREE DAYS LATER THE PATIENT DIED, HOWEVER, THE CAUSE OF DEATH WAS UNKNOWN. A DEATH NOTIFICATION WAS NOT AVAILABLE AND THE OUTCOME OF PERITONITIS WAS NOT REPORTED. A WEEK LATER THE PD NURSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. A DEATH CERTIFICATE WAS REQUESTED, BUT THE NURSE INDICATED THAT THE PD CLINIC WILL NOT RECEIVE THE CERTIFICATE OF DEATH. THE CAUSE OF DEATH WAS UNKNOWN, THOUGH THE NURSE STATED THAT THE DEATH WAS UNRELATED TO DIANEAL THERAPY OR ANY BAXTER DEVICE OR DISPOSABLE PART. TWO WEEKS LATER, THE PD NURSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. IT WAS UNKNOWN IF THE PERITONITIS HAD RESOLVED PRIOR TO DEATH, SINCE THE PD CATHETER HAD BEEN PULLED AND THE PERITONEAL EFFLUENT COULD NOT BE TESTED. THE NURSE STATED SHE DID NOT SEE THE PATIENT AFTER THEY WERE SWITCHED TO HEMODIALYSIS; THEREFORE NO ADDITIONAL INFORMATION WAS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
54035	HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 MO		Death\| H\| R	HOMECHOICE\| EPOGEN\| PREVACID\| SYNTHROID\| VENTILATOR\| DEPAKENE\| DIANEAL PD4 AMBUFLEX