MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K AT HOME MACHINE, SHORT CAB, OLC/DP, H

Device Problems Mechanical Problem (1384); Electronic Property Issue (2928)

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

Event Date 04/01/2015

Event Type  malfunction  

Event Description

A home hemodialysis pt reported to the fresenius field service technician that an issue occurred with the dialysis machine approximately four hours into his treatment.The pt was able to return only half of the blood in his dialysis circuit, resulting in an estimated blood loss of approximately 100ml.No adverse events to the pt were reported.The machine was repaired and ready for use.

Manufacturer Narrative

The device was evaluated in the field by the fresenius service technician who replaced a valve and measured ground between dialysate line grounding point to power supply ground.The plant investigation is in progress.A supplemental medwatch will be submitted once it is complete.

Manufacturer Narrative

The device was not returned to the mfr for physical evaluation and the failure mode cannot be confirmed.A valve was replaced as a preventative measure during field service investigation.After the valve was replaced, the machine passed testing and was deemed ready for use.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 device record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008K AT HOME MACHINE, SHORT CAB, OLC/DP, H
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT, 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: 4901457
• MDR Text Key: 6065075
• Report Number: 2937457-2015-01243
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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