MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008T HEMODIALYSIS SYS., WITH CDX; KDI

Device Problems Thermal Decomposition of Device (1071); Burst Container or Vessel (1074); Material Separation (1562)

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

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician reported a machine was unable to power up, and after examination it was revealed a heater rod had been damaged.The heater rod appeared burnt and charred in one section, and a portion of the rod was completely split open.The damaged heater rod is available and has been requested for investigation, and a picture was also available for review.There was no patient involvement, no harm or adverse event.The facility was not damaged and no staff workers were affected.

Manufacturer Narrative

The heater rod was returned to the manufacturer for physical evaluation.A visual examination of the returned device revealed the presence of a bulge and split in the heater rod.Additionally, discoloration could be seen around the bulge where it had split open.The discoloration was due to excessive heat from the heater rod.The heater rod's coil was visible through the split.A functional test was performed by installing the damaged heater rod into a working unit.The unit was not able to pass the machine self-test with the heater rod installed.Therefore, the machine self-tests could not be performed due to the return condition and the physical damage present to the heater rod.The electrical resistance of the heater rod was measured which revealed an open coil.No noxious smells were encountered during the electrical resistance testing.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.The investigation into the cause of the reported problem was able to confirm the failure modes of physical damage and machine not able to power up.Although a visual examination revealed discoloration which was attributed to excessive heat, the device return condition prevented the reportable malfunction from being duplicated.Therefore, the reportable failure mode was not able to be confirmed.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: KDI
• 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: 5297397
• MDR Text Key: 33509171
• Report Number: 2937457-2015-01701
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113427
• 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: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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