FDA Adverse Event Malfunction Summary report: N

2008T HEMODIALYSIS SYS, WITH CDX

MDR report key: 3822732 · Received February 7, 2014

Report

Report Number: 2937457-2014-00183
Event Type: Malfunction
Date Received: February 7, 2014
Date of Event: January 9, 2014
Report Date: January 9, 2014
Manufacturer: FRESENIUS MEDICAL CARE NORTH AMERICA
Product Code: KDI
PMA / PMN Number: K093902
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION FINDING TO DATE INDICATE THE REPORTED MALFUNCTION OCCURRED DURING RECIRCULATION AND PRIME (MACHINE SET-UP) AND NOT DURING ANALYSIS MODE. THE USER VISUALLY OBSERVED THE SALINE BAG REFILLING WITH DIALYSATE DURING CIRCULATION. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THIS REPORTED ISSUE. THIS REPORT IS BEING INVESTIGATED BY THE MFR VIA A CAPA. THE INVESTIGATION IS PENDING; A SUPPLEMENTAL MDR WILL BE FILED AT THE COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

A BIOMEDICAL TECH REPORTED A LEAK COMING FROM THE DIALYZER CONNECTOR AND A SALINE BAG FILL INCIDENT DURING SET UP. IT OCCURRED WHEN THE TECH REMOVED THE BLUE DIALYZER CONNECTOR FROM THE SHUNT AND FLUID ESCAPED FROM THE DIALYZER CONNECTOR UNEXPECTEDLY. THE TECH WAS NOT AWARE IF THE MACHINE GAVE A DOOR OPEN MESSAGE. THE LEAK CONTINUED UNTIL THE RED DIALYZER CONNECTOR WAS IN PLACE. AT THIS TIME THE TECH OBSERVED THAT THE SALINE BAG STARTED TO FILL AND THE MACHINE WAS REMOVED FROM SERVICE. THERE WAS NO PT INVOLVEMENT DURING THIS INCIDENT. THE AIR SEPARATION CHAMBER ASSEMBLY AND VALVE 43 WERE REPLACED BY THE TECH. THE INCIDENT COULD NOT BE DUPLICATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
81025	2008T HEMODIALYSIS SYS, WITH CDX		KDI	FRESENIUS MEDICAL CARE NORTH AMERICA

Patients

Seq	Age	Sex	Outcome	Treatment
1				UNK SALINE (DISCARDED - NOT USED)\| DIALYZER