FDA Adverse Event Malfunction Summary report: N

XENIUM XPH

MDR report key: 2974698 · Received February 22, 2013

Report

Report Number: 1416980-2013-04494
Event Type: Malfunction
Date Received: February 22, 2013
Date of Event: January 29, 2013
Report Date: January 29, 2013
Manufacturer: NIPRO CORPORATION *USD*
Product Code: KDI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ACTUAL SAMPLE WAS DISCARDED BY THE CUSTOMER. HOWEVER, A RETAINED SAMPLE FROM THE SAME LOT WAS VISUALLY AND FUNCTIONALLY TESTED BY NIPRO WITH NO DAMAGE OR LEAKS NOTED. THE REPORTED CONDITION WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A MANUFACTURING BATCH RECORD REVIEW WAS PERFORMED BY (B)(4) WITH NO ISSUES OR ABNORMALITIES NOTED DURING THE MANUFACTURE OF THIS LOT. THE COMPLAINANT INDICATED THAT THESE DEVICES WERE RESTERILIZED BY CHEMICAL METHODS AND REUSED 3 TIMES. PER THE PRODUCT LABEL, THIS IS A SINGLE USE DEVICE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A DIALYZER HAD A BLOOD LEAK DURING HEMODIALYSIS THERAPY. THE LEAK WAS OBSERVED ON THE SEALING OF THE DIALYZER'S VENOUS CAP. THE ESTIMATED BLOOD LOSS FOR THE PATIENT WAS 100ML. HEMODIALYSIS THERAPY RESUMED WITH A NEW DIALYZER FROM A DIFFERENT BATCH. THE NURSE STATED THAT THE ISSUE WAS OBSERVED DURING THE DIALYZER'S THIRD USE AND THE DIALYZER HAD BEEN REPROCESSED WITH AN AUTOMATED REUSE SYSTEM. THE NURSE ALSO STATED THAT THE DIALYZER PASSED A LEAK TEST PRIOR TO PATIENT USE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT MEDICAL INJURY OR ADVERSE EVENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
78278	XENIUM XPH	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	NIPRO CORPORATION USD		12G05B

Patients

Seq	Age	Sex	Outcome	Treatment
1