MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K HEMODIALYSIS

Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2014

Event Type  malfunction  

Event Description

It was reported by the user facility that the saline bag back-filled during recirculation.There was no pt involvement.The biomedical tech was unable to replicate the issue.Valve 43 was replaced and there was a leak in the flow pump and some crystalized particles around the flow regulator.The flow pump was adjusted and the machine has not had this issues ever since.

Manufacturer Narrative

Investigation findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and typically not during dialysis mode.The saline bag refilling with dialysate was generally observed visually during recirculation.There have been no adverse events associated with the reported issue.The device was not returned to the mfr for physical eval and the failure mode cannot be confirmed.The customer replaced valve v43, but the parts were not returned for investigation.However, an investigation of the device mfg records was conducted by the mfr.There were no deviations or non-conformances discovered during the mfg process.In addition, the batch record review confirmed the labeling, material, and process controls were within spec.

• Brand Name: 2008K HEMODIALYSIS
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord MA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: corie vazquez ; 920 winter st; waltham, MA 02451-1457 ; 7816999071
• MDR Report Key: 4309659
• MDR Text Key: 18261380
• Report Number: 2937457-2014-03205
• Device Sequence Number: 1
• Product Code: FKX
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• 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: 05/10/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2007
• 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
• Treatment: UNK SALINE (DISCARDED-NOT USED)