MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS

Model Number K2

Device Problems Electrical /Electronic Property Problem (1198); Arcing (2583); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

The parts were not returned to the mfr for physical eval and the plant investigation is on-going.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility reported an electrical arc within a hemodialysis machine.The biomed tech (bmt) reported a small "nick" in the cable of the actuator board.The bmt theorized the exposed part of the wire came into contact with the chasis of the hemodialysis machine, thus causing an electrical arc.There was no visual or otherwise reported sense of smoke, flame, or spark.The bmt installed a new actuator board and the machine a now back in service.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and field service was not requested, therefore, the failure mode cannot be confirmed.However, a records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the dhr record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5335812
• MDR Text Key: 34705219
• Report Number: 2937457-2015-01740
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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