FDA Adverse Event Malfunction Summary report: N

LIBERTY CYCLER

MDR report key: 3099284 · Received May 2, 2013

Report

Report Number: 2937457-2013-00053
Event Type: Malfunction
Date Received: May 2, 2013
Date of Event: April 6, 2013
Report Date: April 6, 2013
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

THE PT HAS REPORTED AN OVERFILL GREATER THAN 200% OF THE PRESCRIBED VOLUME. THE LARGE DRAIN VOLUME OF 7783ML CANNOT BE EXPLAINED. THE CYCLER HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A SUPPLEMENTAL MDR REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

A PERITONEAL DIALYSIS RN CALLED TECH SUPPORT BECAUSE SHE RECEIVED A CALL FROM THE PT WHO STATED THAT THE CYCLER HAD A LARGE UF AMOUNT FROM LAST NIGHT'S TREATMENT. THE RN WANTED TO KNOW WHAT WOULD CAUSE THIS. TECH SUPPORT EXPLAINED A POSSIBLE CAUSE AND OFFERED TO CONTACT THE PT FOR ADD'L INFO. THE PT PROVIDED THE FOLLOWING TREATMENT DATA; 0 230 2B 29; 1 2605 13 60 2401 14 -205; 2 2404 11 72 2394 13-11; 3 2401 12 73 2413 14 11; 4 2397 13 72 2391 13-6; 5 2401 11 73 2413 13 12; 6 2404 11 73 7783 43B 5378; 7 201 2. THE PT'S PD RN WAS CONTACTED REGARDING THE REPORTED OVERFILL. RN STATED THAT THE EVENT DID OCCUR AND THAT NO SERIOUS INJURY OCCURRED AT THE TIME. THE PT CONTINUES WITH THE CCPD PROGRAM IN STABLE CONDITION WITH THE REPLACEMENT CYCLER. THE LARGE DRAIN VOLUME OF 7783ML, WHICH CANNOT BE EXPLAINED IS GREATER THAN 200% OF THE PRESCRIBED FILL VOLUME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
192804	LIBERTY CYCLER	PERITONEAL DIALYSIS CYCLER	FKX	FRESENIUS MEDICAL CARE NORTH AMERICA	LIBERTY

Patients

Seq	Age	Sex	Outcome	Treatment
1				DELFEX PD SOLUTION\| LIBERTY CYCLER SET