FDA Adverse Event Injury Summary report: N

HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR.

MDR report key: 1133244 · Received August 21, 2008

Report

Report Number
1423500-2008-00761
Event Type
Injury
Date Received
August 21, 2008
Report Date
August 6, 2008
Manufacturer
BAXTER HEALTHCARE SA - SINGAPORE,
Product Code
FKX
PMA / PMN Number
K923065
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SP
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IN 2008, THE CUSTOMER CONTACTED BAXTER HEALTHCARE TO REPORT THAT A HOME PATIENT (HP) DETECTED AIR IN HIS ABDOMEN DURING THE PERITONEAL DIALYSIS NIGHTLY TREATMENT. THE HP SEEMS TO HAVE DETECTED SOME AIR IN THE EQUIPMENT LINES. THE TREATMENT WAS FINALIZED WITHOUT ANY INCIDENT. THE NEXT MORNING, THE HP WENT TO THE HOSPITAL AND WHILE THE NURSE WAS DOING AN EXCHANGE, SHE REALIZED THE HP HAD AIR IN THE PERITONEUM. THE AIR WAS ELIMINATED THROUGH A MANUAL EXCHANGE. ONE GRAM OF CEFAZOLIN WAS TO BE GIVEN FOR A DURATION OF 3 DAYS AS PROPHYLACTIC TREATMENT. THE NURSE SUSPECTS AIR WAS INFUSED INTO THE PERITONEUM DUE TO DEFECTIVE EQUIPMENT LINES. TWO DAYS LATER, THE HP PRESENTED WITH CLOUDY EFFLUENT AND A PERITONEAL EFFLUENT SAMPLE WAS CULTURED ALTHOUGH THE PATIENT WAS ALREADY RECEIVING PROPHYLACTIC TREATMENT. THE HP WAS THEN PRESCRIBED PROTOCOL TREATMENT FOR PERITONITIS WHICH INCLUDED VANCOMYCIN, TOBRAMICIN, AND AMPICILLIN INTRAPERITONEALLY (SPECIFIC DOSES UNKNOWN). THE AMPICILLIN WAS TO BE WITHDRAWN 48 HRS LATER AND THE REST OF THE ANTIBIOTICS WERE TO BE KEPT THE SAME FOR A TOTAL OF 14 DAYS. THE NEXT DAY, THE EFFLUENT WAS REPORTED TO BE CLEAR. FOUR DAYS LATER, THE PERITONEAL CULTURE WAS REPORTED TO BE NEGATIVE. THE HP HAS NOT HAD ANY OTHER PERITONITIS EPISODES OR EXIT SITE INFECTIONS IN THE LAST 6 MONTHS. THE HP WAS NOT ADMITTED TO THE HOSPITAL AND HE IS REPORTEDLY DOING FINE ON PERITONEAL DIALYSIS AND IS RECOVERING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR. 78FKX FKX BAXTER HEALTHCARE SA - SINGAPORE, S08E03062

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention