FDA Adverse Event Malfunction Summary report: N

2008K2 HEMODIALSYS. OLC/DIASAFE PLS

MDR report key: 3881589 · Received April 9, 2014

Report

Report Number: 2937457-2014-00548
Event Type: Malfunction
Date Received: April 9, 2014
Date of Event: March 19, 2014
Report Date: March 19, 2014
Manufacturer: CONCORD MANUFACTURING
Product Code: KDI
PMA / PMN Number: K994267
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATIONS FINDINGS TO DATE INDICATE THE REPORTED MALFUNCTION OCCURRED DURING RECIRCULATION AND PRIME (MACHINE SET-UP), AND NOT DURING DIALYSIS MODE. THE USER VISUALLY OBSERVED THE SALINE BAG REFILLING WITH DIALYSATE DURING CIRCULATION. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE. THE REPORT IS BEING INVESTIGATED BY THE MANUFACTURER 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 USER FACILITY REPORTED A SALINE BAG BACK FILLED DURING RECIRCULATION MODE. A PT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. A FRESENIUS TECHNICIAN WENT IN TO THE FACILITY AND SUGGESTED TO THE FACILITY BIOMED THAT THE FLOW PRESSURE REGULATORY AND THE LOADING PRESSURE REGULATOR SHOULD BE REPAIRED. THE FRESENIUS TECH REPAIRED THE EQUIPMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
214186	2008K2 HEMODIALSYS. OLC/DIASAFE PLS		KDI	CONCORD MANUFACTURING

Patients

Seq	Age	Sex	Outcome	Treatment
1				UNK SALINE (DISCARDED-NO USED)