FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2874003 · Received December 14, 2012

Report

Report Number: 1416980-2012-07359
Event Type: Malfunction
Date Received: December 14, 2012
Date of Event: December 10, 2012
Report Date: December 10, 2012
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 SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REPORTING A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 3 OF 5 ON THE HOMECHOICE (HC). THE CAREGIVER (CG) STATED THE SUPPLY BAG BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG CYCLE THE POWER AND THE HC THEN ALARMED SYSTEM ERROR 2367 OCCURRED. THE TSR HAD THE HOME PATIENT (HP) CYCLE THE POWER AGAIN AND ALARMS CLEARED. THE CG TO COMPLETE THERAPY MANUALLY. PER THE BAXTER TECHNICAL SERVICES REPRESENTATIVE, SAMPLES AND LOT NUMBERS WERE UNAVAILABLE. 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
1	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR			HOMECHOICE