MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLS

Catalog Number 190610

Device Problems Circuit Failure (1089); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Electrical Shorting (2926)

Patient Problem Blood Loss (2597)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant's investigation.

Event Description

A user facility reported that during patient treatment a machine shut down and gave off a burning smell.The hemodialysis nurse could not return the blood in the bloodline to the patient and treatment was discontinued.The patient disconnected from treatment and did not resume on another machine.The malfunction occurred near the end of the scheduled therapy.The blood in the combi-set was not able to be returned to patient, but the patient did not loose a significant amount of blood according to biomed tech.During repair, the biomed technician discovered capacitor c27 on the power logic power control board had popped.The power control board was replaced and the machine was returned to service.There was no patient harm or adverse event, and no medical intervention was required.

Manufacturer Narrative

The actual device was not evaluated by fresenius personnel therefore the failure mode cannot be confirmed or replicated in field testing.However, the facility reported that the issue was resolved by replacing the power logic board of the unit.The issue has not occurred again and the machine is operational an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformities during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material and process controls were within specification.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5305594
• MDR Text Key: 33779208
• Report Number: 2937457-2015-01710
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1