FDA Adverse Event Malfunction Summary report: N

LIBERTY CYCLER

MDR report key: 3021195 · Received March 21, 2013

Report

Report Number: 2937457-2013-00035
Event Type: Malfunction
Date Received: March 21, 2013
Date of Event: February 22, 2013
Report Date: February 22, 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 OF 225% OVER THE PRESCRIBED AMOUNT. THE CYCLER WILL BE RETURNED FOR EVAL. A SUPPLEMENTAL MDR REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

ON (B)(6) 2013, THE PT (PT) CALLED TECHNICAL SUPPORT WHILE IN DRAIN 0 OF 4 AND STATED HE WAS DRAINING VERY SLOW. PT HAD DRAINED 690/2000 WHEN HE CALLED. THE PT CALLED BACK AND STATED HE LEFT EMPTY AND WAS HAVING PULLING SENSATION. PT BYPASSED INTO FILL 1 AND STAYED ON THE LINE WITH PT WHILE FILLING. PT FILLED BUT STATED HE LEFT FULL. PT DID A STAT DRAIN AND PT STATED HE FELT BETTER. UPON F/U WITH THE PT TO OBTAIN ADD'L INFO, THE PT'S SON STATED THAT DRAIN 0 IS TYPICALLY 1900 ML TO 2200 ML. PT WAS BYPASSED OUT OF DRAIN 0 DUE TO FEELING EMPTY. DURING FILL 1 PT FELT FULL AND PT WAS DISCONNECTED THEN A MANUAL DRAIN WAS PERFORMED, OBTAINING 4500 ML. UPON DRAINING, PT FELT BETTER AND SYMPTOMS RESOLVED. A REPLACEMENT CYCLER WAS OBTAINED AND HE HAS HAD NO FURTHER PROBLEMS. ON (B)(6) 2013, THE PERITONEAL DIALYSIS (PD) NURSE STATED THE PT DID NOT HAVE AN ADVERSE EFFECT AS A RESULT. THE PD NURSE STATED THE PT HAD BROUGHT HIS IQ DRIVE BUT THERE WAS NO TREATMENT INFO OR DATA RECORDED. THE IQ DRIVE WAS REPROGRAMMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
118872	LIBERTY CYCLER	PERITONEAL DIALYSIS CYCLER	FKX	FRESENIUS MEDICAL CARE NORTH AMERICA	LIB

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR			LIBERTY CYCLER SET