FDA Adverse Event Injury Summary report: N

INTEGRATED APO SET W/CASSETTE3-PRONG

MDR report key: 1241034 · Received November 21, 2008

Report

Report Number
1423500-2008-00929
Event Type
Injury
Date Received
November 21, 2008
Date of Event
October 8, 2008
Report Date
October 8, 2008
Manufacturer
BAXTER HEALTHCARE
Product Code
FKX
PMA / PMN Number
K923065
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

IN 2008, A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM DURING DWELL 3 OF 4 WHILE USING THE HOME CHOICE DEVICE. TWENTY DAYS LATER, THE HOME PATIENT'S (HP) PERITONEAL DIALYSIS (PD) NURSE WAS CONTACTED AND SHE STATED THE HP DEVELOPED PERITONITIS. TWO DAYS LATER, THE NURSE WAS ALSO CONTACTED AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: ON THE DATE OF DIAGNOSIS (FOUR DAYS AFTER THE ORIGINAL DATE) A CELL COUNT WAS PERFORMED SHOWING THE LEUKOCYTE COUNT WAS 2214 AND THE NEUTROPHIL COUNT WAS 94%. THE GRAM STAIN WAS POSITIVE FOR STAPHYLOCOCCUS COAGULASE-NEGATIVE AND A CULTURE TAKEN OF THE PERITONEAL EFFLUENT ON THE SAME DATE IDENTIFIED STAPHYLOCOCCUS EPIDERMIDIS. THE HP WAS NOT HOSPITALIZED FOR THE PERITONITIS; HOWEVER, THE HP WAS GIVEN KEFZOL (DOSE AND ROUTE UNKNOWN) FOR ELEVEN DAYS FROM THAT DAY. THERE WAS NO EXIT SITE OR TUNNEL INFECTION. THE NURSE DID NOT HAVE ANY INPUT INTO THE CAUSE OF THE PERITONITIS. THE PATIENT HAS REPORTEDLY RECOVERED FROM THIS PERITONITIS EPISODE (DATE UNKNOWN).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INTEGRATED APO SET W/CASSETTE3-PRONG 78FKX FKX BAXTER HEALTHCARE

Patients

Seq Age Sex Outcome Treatment
1 71 YR Required Intervention