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

Device Problems Inadequate Filtration Process (2308); Device Operates Differently Than Expected (2913)

Patient Problem Hypervolemia (2664)

Event Date 07/09/2015

Event Type  Injury  

Manufacturer Narrative

Additional information including treatment record has been requested but not yet received.The plant investigation is in progress and a supplemental medwatch will be submitted.

Event Description

A biomedical technician called technical support to report that an ultrafiltration (uf) problem occurred during the treatment of a hemodialysis patient, and that no fluid removal occurred.Although a uf time and goal was entered, the uf rate and uf removal was set to zero.This was discovered at the end of the treatment and the patient required an additional dialysis treatment the following day for fluid removal.No further medical intervention was required.

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, 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 batch record review confirmed the labeling, material, and process controls were within specification.Multiple attempts to obtain the status of the machine, and patient information have been unsuccessful.

• Brand Name: 2008T HEMODIALYSIS SYS. WITH CDX
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham , MA 02451 ; 8006621237
• MDR Report Key: 4987891
• MDR Text Key: 22536148
• Report Number: 2937457-2015-01314
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 83