FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2895702 · Received January 3, 2013

Report

Report Number: 1416980-2013-00229
Event Type: Malfunction
Date Received: January 3, 2013
Date of Event: December 24, 2012
Report Date: December 24, 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). THIS COMPLAINT FOR A REPORT OF USE ERROR - REUSE OF SINGLE-USE SUPPLIES WAS CONFIRMED, BASED ON THE CUSTOMER REPORT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED SINCE IT IS UNCERTAIN WHY THE PATIENT REUSED SINGLE USE PRODUCT. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF THE USE ERROR IN THIS REPORT.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING THERAPY ASSISTANCE WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 4 OF 4. THE HOME PATIENT (HP) STATED THAT HE DID NOT KNOW THAT THE SOLUTION FROM THE SUPPLY BAG REFILLED THE HEATER, SO HE DISCONNECTED THE BAG AND RECONNECTED IT TO THE HEATER. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE REFILLING PROCESS AND ADVISED THAT HE WOULD NEED TO END THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(6) 2013. SHE STATED THAT SHE HAD SPOKEN WITH THE PATIENT REGARDING THIS EVENT. HE HAS BEEN DOING WELL SINCE, AND NO ADVERSE EFFECTS WERE REPORTED IN RELATION TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
3214	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR			HOMECHOICE