MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2 HEMODIALYSIS SYS

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

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2013

Event Type  malfunction  

Event Description

It was reported by the user facility that while priming/recirculating bloodlines and dialyzer, noticed the saline bag filling; also noticed the fill program alarm present.A patient was not connected to the machine at the time of the incident.The nurse discarded tubing/dialyzer, and reset up with new supplies.The machine continued service with no further issue reported.

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 user visually observed the saline bag refilling with dialysate during circulation.There have been on adverse events associated with the reported issue.As per field service report could not duplicate the saline bag back fill, ran recirculation 3 times.The venous module was replaced for precaution and recalibrated venous pressure and air detector.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008K2 HEMODIALYSIS SYS
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: corie vasquez, manager ; 920 winter st; waltham, MA 02451-1457 ; 7816999071
• MDR Report Key: 4309648
• MDR Text Key: 19348462
• Report Number: 2937457-2014-03228
• 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: 08/16/2013

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: 08/16/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2010
• 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: UNKNOWN SALINE (DISCARDED-NOT USED)