FDA Adverse Event Malfunction Summary report: N

PD CYCLER 110 VOLT HOME CHOICE PRO AUTOMATED

MDR report key: 1030328 · Received April 16, 2008

Report

Report Number: 1423500-2008-00255
Event Type: Malfunction
Date Received: April 16, 2008
Date of Event: February 12, 2008
Report Date: April 7, 2008
Manufacturer: BAXTER HEALTHCARE
Product Code: FKX
PMA / PMN Number: K012988
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADD'L 510K#: K923065. EVAL SUMMARY: THE EVAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS OVERFILL DISCOVERED DURING EVAL. THE THERAPY LOGS DID NOT CONTAIN SUFFICIENT DATA TO DETERMINE A PROBABLE CAUSE OF THE OVERFILL. HOWEVER, WITH A LAST FILL VOLUME OF 2000ML AND THE INITIAL DRAIN ALARM PROGRAMMED AT 0ML, THERE IS THE POTENTIAL OF INSUFFICIENT DRAIN DUE TO A FALSE EMPTY DETECT AND USER ERROR/INITIAL DRAIN SETTING INAPPROPRIATELY PROGRAMMED TOO LOW. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

Description of Event or Problem · 1

DURING EVAL OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED IN 2008, DURING DRAIN CYCLE 1. THE PT'S ULTRAFILTRATION READING WAS 2032 ML INDICATING THE HOME PT (HP) DRAINED 2032 ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 3000ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 5032ML (3000ML + 2032ML). FOLLOW UP WITH THE PT'S NURSE CONFIRMED THAT THE HP IS DOING FINE AND HAS BEEN ABLE TO CONTINUE PERITONEAL DIALYSIS THERAPY WITHOUT ANY FURTHER PROBLEMS. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DESPITE ATTEMPTS BY BAXTER, NO ADD'L INFO COULD BE OBTAINED REGARDING THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PD CYCLER 110 VOLT HOME CHOICE PRO AUTOMATED	78FKX	FKX	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1