FDA Adverse Event Other Summary report: N

LIBERTY CYCLER

MDR report key: 2926404 · Received January 15, 2013

Report

Report Number: 2937457-2013-00003
Event Type: Other
Date Received: January 15, 2013
Date of Event: December 17, 2012
Report Date: December 17, 2012
Manufacturer: FRESENIUS MEDICAL CARE NORTH AMERICA
Product Code: FKX
PMA / PMN Number: K043363
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

A MEDICAL REVIEW WAS PERFORMED ON THE INFO AND TREATMENT DATA PROVIDED. A LARGE DRAIN VOLUME WAS REPORTED IN DRAIN 0 AND IN DRAIN 1. PATIENT WAS ASYMPTOMATIC AND DID NOT HAVE AN ADVERSE EFFECT AS A RESULT OF THE LARGE DRAIN. THE CYCLER WILL BE EVALUATED UPON RETURN TO THE MFR AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

Description of Event or Problem · 1

THE PT REPORTED THE PREVIOUS CCPD TREATMENT WAS COMPLETED WITH A LAST FILL 2000 ML WITHOUT PROBLEM. THE PATIENT REPORTED SHE DID A MID-DAY MANUAL EXCHANGE, THE PATIENT REPORTED SHE COULD NOT REMEMBER THE VOLUME DRAINED. THE PATIENT THEN FILLED WITH 2000 ML. THE PATIENT SET UP THE LIBERTY CYCLER WITH TWO FIVE LITER BAGS OF FLUID. UPON CONNECTING TO THE CYCLER, THE PATIENT DRAINED 4633 M. PATIENT STATED THIS VOLUME WAS UNUSUALLY LARGE BUT DID NOT FEEL ANY SYMPTOMS AND CONTINUED THE TREATMENT. FILL 1: 2000 ML AND DRAIN 1: 7350 ML. FILL 2: 2000 ML AND DRAIN 2: 1324 ML, THE PATIENT THEN STOPPED THE TREATMENT. THE PATIENT REPORTED THAT THE TWO SOLUTION BAGS WERE EMPTY AT THAT TIME AND THERE WERE ALARMS BUT SHE COULD NOT RECALL THE EXACT ALARMS. THE PATIENT DENIED FEELING SYMPTOMS, FULLNESS, OR DISCOMFORT. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT AS A RESULT OF THE LARGE DRAIN VOLUME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
22534	LIBERTY CYCLER	PERITONEAL DIALYSIS CYCLER	FKX	FRESENIUS MEDICAL CARE NORTH AMERICA	LIBERTY CYCLER

Patients

Seq	Age	Sex	Outcome	Treatment
1