FDA Adverse Event Malfunction Summary report: N

LIBERTY CYCLER

MDR report key: 3772293 · Received December 19, 2013

Report

Report Number: 2937457-2013-00554
Event Type: Malfunction
Date Received: December 19, 2013
Date of Event: October 1, 2013
Report Date: December 3, 2013
Manufacturer: FRESENIUS MEDICAL CARE NORTH AMERICA
Product Code: FKX
PMA / PMN Number: K043363
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

A REVIEW WAS PERFORMED BY THE POST MARKET CLINICAL DEPARTMENT OF THE TREATMENT DATA PROVIDED. A LARGE INTRA-PERITONEAL VOLUME DRAIN OCCURRED IN DRAIN 4 WITH AN UNDETERMINED CAUSE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED LARGE DRAIN VOLUME. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. RELATED MDRS 2937457-2013-00554, 2937457-2013-00555 AND 2937457-2013-00556.

Description of Event or Problem · 1

THE PERITONEAL DIALYSIS (PD) NURSE REPORTED LARGE DRAIN VOLUMES. TREATMENT DATA PROVIDED BELOW: THE REPORTED DRAIN VOLUME OF 4509 ML WAS 181% OVER THE EXPECTED DRAIN VOLUME WHICH RESULTED IN A REPORTABLE DEVICE MALFUNCTION. THE PATIENT'S PD RN CONFIRMED NO MEDICAL INTERVENTION WAS REQUIRED DURING OR FOLLOWING THIS EVENT. THE PATIENT CONTINUED WITH HIS PD PROGRAM AND IS IN STABLE CONDITION. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THE REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
667690	LIBERTY CYCLER		FKX	FRESENIUS MEDICAL CARE NORTH AMERICA

Patients

Seq	Age	Sex	Outcome	Treatment
1				LIBERY CYCLER CASSETTE