FDA Adverse Event Malfunction Summary report: N

PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

MDR report key: 1931551 · Received December 17, 2010

Report

Report Number: 1423500-2010-06999
Event Type: Malfunction
Date Received: December 17, 2010
Date of Event: November 7, 2010
Report Date: November 24, 2010
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K053512
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 HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

(B)(4). THE IIPV WAS CONFIRMED THROUGH THE DEVICE LOG, BUT NOT DUPLICATED. THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT DRAIN, ONE OR MORE CYCLES ADVANCES TO THE NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MIN DRAIN VOLUME THRESHOLD. REVIEW OF THE SERVICE DATES AND ACTIVITIES REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR THE REPORTED PROBLEMS OF IIPV. THE DEVICE MET SPECIFICATIONS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

Description of Event or Problem · 1

DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE DEVICE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE ULTRAFILTRATION VOLUME WAS 1108ML. THIS EVENT MEETS OVERFILL CRITERIA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR