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

Catalog Number 190371

Device Problems Electrical /Electronic Property Problem (1198); Fire (1245); Smoking (1585); Out-Of-Box Failure (2311); Sparking (2595); Electrical Shorting (2926); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

A hemodialysis facility reported a power supply unit for one of the machines began to smoke upon installation.A biomedical technician also noticed sparks coming from the unit and immediately turned the machine off.There was no pt involvement and no treatment occurred.The malfunction occurred during installation/set-up and was the first time the replacement part had been used.There was no serious injury or adverse event, the unit was disconnected and returned for evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

The actual device component was returned to the manufacturer for physical evaluation.A visual inspection of the power supply board revealed a burnt capacitor.The complaint was confirmed as a known hazard/failure mode with a known cause that had been adequately controlled for risk.An investigation of the device manufacturing records was conducted by the manufacturer.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• 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, rn cnor ; 920 winter st. ; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4801768
• MDR Text Key: 5829388
• Report Number: 2937457-2015-00995
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1