FDA Adverse Event Injury Summary report: N

HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT

MDR report key: 188084 · Received September 16, 1998

Report

Report Number
1423500-1998-01703
Event Type
Injury
Date Received
September 16, 1998
Date of Event
July 1, 1998
Report Date
September 2, 1998
Manufacturer
BAXTER HEALTHCARE CORP.
Product Code
FKX
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NH, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

RN CALLED TO REQUEST FURTHER INFORMATION ON EOSINOPHILIC PERITONITIS. RN REPORTS PATIENT HAD CULTURE DONE WHICH SHOWED NO GROWTH. PATIENT WAS STARTED ON ANCEF 500 MG LOADING DOSE FOLLOWED BY 250 MG/BAG X 14 DAYS ALONG WITH GENTAMYCIN 40 MG X 2 DAYS. PATIENT AFTER TREATMENT AGAIN PRESENTED WITH CLOUDY BAG AND WHITE BLOOD CELLS OF 420. ON 8/29/98, GENTAMYCIN RESTARTED AT 16 MG X 6 DOSES. RN STATES FUNGAL CULTURE WAS SENT OUT FOR PATIENT ON 8/30/98. RN REFUSES TO GIVE ANY FURTHER INFORMATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT HOMECHOICE FKX BAXTER HEALTHCARE CORP. NA NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Other