FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2872900 · Received December 13, 2012

Report

Report Number: 1416980-2012-07290
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: November 24, 2012
Report Date: November 26, 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 A USE ERROR - REUSE OF SINGLE-USE PRODUCT ISSUE IS CONFIRMED BECAUSE IT WAS REPORTED DURING AN ALARM SITUATION CHECK HEATER LINE, THAT THE CUSTOMER SWAPPED A SOLUTION BAG ONLY, WHICH IS A USE ERROR/POOR ASEPTIC TECHNIQUE. THE ASSIGNABLE CAUSE WAS UNDETERMINED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

Additional Manufacturer Narrative · 1

(B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REPORTING AN ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING FILL 1. DURING THIS TIME, THE HP DISCONNECTED AND CONNECTED ANOTHER BAG. THE HP ENDED THERAPY. 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	50 YR			HOMECHOICE