FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3071564 · Received April 22, 2013

Report

Report Number: 1416980-2013-10034
Event Type: Malfunction
Date Received: April 22, 2013
Date of Event: April 10, 2013
Report Date: April 10, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

(B)(4). THE SYSTEM ERROR 2240 ALARM IS CONFIRMED DUE TO THE INCOMPLETE PRIME DESCRIBED BY THE PATIENT, WHICH CAN INTRODUCE AIR INTO THE SYSTEM AND CAUSE THE ALARM. THE PATIENT PRIMED THE DISPOSABLE SET PRIOR TO ATTACHING THE PATIENT LINE EXTENSION, CAUSING THE INCOMPLETE PRIME.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THIS WAS THE FIRST TIME THE HP WAS TRYING TO USE A PATIENT LINE EXTENSION AND THEY ATTACHED IT AFTER PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINS PROPER SETUP AND HAD THE HOME PATIENT (HP) CYCLE THE POWER FOR SYSTEM ERROR 2367 THEN AGAIN TO CLEAR ALARMS. THE HP TO SETUP WITH NEW SUPPLIES. THE HC WAS OKAY. 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
171285	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR			HOMECHOICE