FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 2926446 · Received January 23, 2013

Report

Report Number: 1416980-2013-01691
Event Type: Malfunction
Date Received: January 23, 2013
Date of Event: January 9, 2013
Report Date: January 9, 2013
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: SERVICE AND TESTING PERSONNEL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE FOR THE ISSUE OF FAILED HOMECHOICE (HC) RETURN INSTRUMENT TEST/EVALUATION (RITE) FAILED FUNCTIONAL TEST FOR THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION: FILL 1 834.7 ML, DRAIN 1 834.7 ML, FILL 2 834.4 ML, DRAIN 2 834.5 ML (RITE SPECIFICATIONS 774 - 821 ML). THE PAL EVALUATED THE DEVICE. ACCURACY CONFIRMATION TEST WAS PERFORMED AND DEVICE FAILED. AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND DETERIORATED PISTON FOAM WAS REVEALED. THE ASSIGNABLE CAUSE OF THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION WAS DETERMINED TO BE DETERIORATED PISTON FOAM. PISTON FOAM WILL BE SCRAPPED. DEVICE WAS SENT TO SERVICING.

Description of Event or Problem · 1

THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HOMECHOICE (HC) MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC: FILL 1 834.7 ML, DRAIN 1 834.7 ML, FILL 2 834.4 ML, DRAIN 2 834.5 ML. PER CQI56 A FILL/DRAIN 1 OR 2 VOLUME OUTSIDE RANGE 750.0 ML - 828.2 ML IS REPORTABLE. RITE TEST FAILURE, NO PATIENT INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
32859	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1