FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2933060 · Received January 29, 2013

Report

Report Number: 1416980-2013-02130
Event Type: Malfunction
Date Received: January 29, 2013
Date of Event: January 20, 2013
Report Date: January 20, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 3. THE HP POWER CYCLED THE HC. THE HC ALARMED SE 2367 AND THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP POWER CYCLE THE HC. THE HC PROCEEDED TO PRESS GO TO START AND THE HP STATED ONE OF THE UNUSED SUPPLY LINE CLAMPS WAS OPEN. THE TSR ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES OR PERFORM CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) TO COMPLETE THERAPY AND TO INFORM THE REGISTERED NURSE (RN) OF THE SE 2240. THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
39454	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR			HOME CHOICE