FDA Adverse Event Other Summary report: N

HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

MDR report key: 622794 · Received August 11, 2004

Report

Report Number
1423500-2004-00852
Event Type
Other
Date Received
August 11, 2004
Date of Event
July 22, 2004
Report Date
July 22, 2004
Manufacturer
BAXTER HEALTHCARE CORPORATION
Product Code
FKX
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

A HOME PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER IN 2004 TO REPORT THAT PATIENT THOUGHT "AIR GOT IN THEIR BELLY" SUBSEQUENT TO THEIR TRANSFER SET BEING CONNECTED TO THE PATIENT LINE OF THE HOMECHOICE SET DURING PRIME IN ANTICIPATION OF THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. REPORTEDLY, THE NIGHT OF THE EVENT, THE HOME PATIENT MISTAKENLY CONNECTED THEMSELF TO THE SET UP DURING PRIME, AND OPENED PATIENT'S TRANSFER SET CLAMP. THE HOME PATIENT NOTICED THE INCORRECT CONNECTION ONCE PRIME HAD COMPLETED. THE HOME PATIENT SETUP WITH ALL NEW SUPPLIES TO PERFORM THERAPY. DURING THE LAST DRAIN, THE HOME PATIENT STATED THAT PATIENT WOKE UP OUT OF SOUND SLEEP DUE TO THE EXTREME SHOULDER AND ABDOMINAL PAIN PATIENT WAS EXPERIENCING. THE HOME PATIENT CONTACTED THEIR DIALYSIS CLINIC THE NEXT DAY WHO ADVISED PATIENT TO GO IN THE CLINIC IF THE PAIN HAD NOT DISSIPATED BY THE FOLLOWING MORNING. THE HOME PATIENT REPORTED THAT THE PAIN DISSIPATED BEFORE THE MORNING OF SAME DAY, THEREFORE THE HOME PATIENT DID NOT GO INTO THE CLINIC. NO MEDICAL INTERVENTION WAS REQUIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

Patients

Seq Age Sex Outcome Treatment
1 51 YR Other