FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2002016 · Received February 27, 2011

Report

Report Number: 1423500-2011-02472
Event Type: Malfunction
Date Received: February 27, 2011
Date of Event: February 5, 2011
Report Date: February 5, 2011
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

Description of Event or Problem · 1

A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (S/E) 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) MACHINE DURING DWELL 2 OF 3. THE HP WAS CONNECTED AT THE TIME OF THE ALARM AND DID NOT DISCONNECT ANY TIME PRIOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM INDICATES AIR ENTERED THE SET UP AND ASSISTED THE HP TO CYCLE POWER TO THE MACHINE TO CLEAR THE ALARM TO START OVER OR USE MANUAL BAGS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE