FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2923107 · Received January 18, 2013

Report

Report Number: 1416980-2013-01445
Event Type: Malfunction
Date Received: January 18, 2013
Date of Event: December 26, 2012
Report Date: December 26, 2012
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A SAMPLE EVALUATION WAS PERFORMED. A VISUAL INSPECTION WAS PERFORMED AND NO ABNORMALITY WAS OBSERVED. THE THREAD LIKE PARTICLE SEEN BY THE USER COULD BE THE FINE WELD LINE ON THE CASSETTE, WHICH IS ACCEPTABLE. FUNCTIONAL TESTS, INCLUDING A SELF TEST AND PRIMING, WERE PERFORMED WITH NO ABNORMALITIES NOTED. A CLEAR PASSAGE TEST AND PRESSURE TESTS WERE PERFORMED WITH NO ABNORMALITY OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

A NURSE CONTACTED BAXTER (B)(4) REGARDING PARTICULATE MATTER FOUND WITHIN A CASSETTE. THE NURSE STATED THAT A THREAD-LIKE PARTICLE WAS OBSERVED IN THE CASSETTE. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
27222	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE		S12G10026

Patients

Seq	Age	Sex	Outcome	Treatment
1