FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 2924226 · Received January 22, 2013

Report

Report Number: 1416980-2013-01580
Event Type: Malfunction
Date Received: January 22, 2013
Date of Event: December 30, 2012
Report Date: December 30, 2012
Manufacturer: BAXTER HEALTHCARE
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PATIENT

Narratives

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 SAMPLE EVALUATION WILL NOT BE CONDUCTED. HOWEVER, THE PROBLEM WAS CONFIRMED BASED ON THE REUSE OF SUPPLIES LISTED IN THE REPORT. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

Description of Event or Problem · 1

A HOME PATIENT (HP) CONTACTED BAXTER (B)(4), FOR ASSISTANCE WITH A HOME CHOICE (HC) MACHINE, WHICH HAD SOUNDED CHECK LINES AND BAGS. DURING ASSISTANCE THE HP STATED, TO THE TECHNICAL SERVICE REPRESENTATIVE (TSR), THAT THE HEATER BAG WAS EMPTY AND THE LAST FILL BAG HAD SOLUTION. THE HP REQUESTED TO BYPASS THIS ALARM. THE TSR EXPLAINED TO THE HP HAD RAN SHORT OF SOLUTION. THE TSR ASSISTED TO END THERAPY AS REQUESTED AND STATED THE HP SHOULD FOLLOW UP WITH MANUAL EXCHANGES. THE TSR ADVISED THE HP TO LET THE RENAL NURSE (RN) KNOW THAT THE HP RAN SHORT OF SOLUTION. THEN THE HP SAID THAT SHE HAD REUSED SUPPLIES FROM PREVIOUS THERAPY. THE TSR EXPLAINED ABOUT NOT REUSING SUPPLIES AND ADVISED TO LET THE RN KNOW. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED. THERE WERE NO REPORTS OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
31103		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOME CHOICE