FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2073091 · Received April 29, 2011

Report

Report Number: 1423500-2011-05213
Event Type: Malfunction
Date Received: April 29, 2011
Date of Event: February 20, 2011
Report Date: February 20, 2011
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. A POSSIBLE CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. A LABEL REVIEW WAS NOT PERFORMED DUE TO UNSUSPECTED USER ERROR. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

Description of Event or Problem · 1

WHILE FOLLOWING UP WITH A PATIENT, (B)(4) LEARNED THAT THE PATIENT HAD A HOLE IN THE PATIENT LINE, AND AS A RESULT, SOLUTION LEAKED OUT. THE PATIENT STATED SHE DID NOT KNOW WHAT CAUSED THE HOLE AND ONLY NOTICED IT AFTER THERAPY BEGAN. THE PATIENT STATED SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

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	60 YR			HOMECHOICE PRO