MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008T HEMODIALYSIS SYSTEM WITHOUT CDX

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 10/13/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility reported that during treatment a machine experienced a power supply issue.The patient was moved to a different machine to complete treatment.The patient's estimated blood loss was contributed to the bloodline not being rinsed back when the patient was moved to a different machine.The estimated blood loss was 300 ml.The patient completed treatment with a new set up.The patient has no adverse effects and no medical intervention was required.The power logic board was replaced on the machine during the manufacturer's field service and machine was placed back in service.Additional attempts to the customer have been made without any additional information provided.

Manufacturer Narrative

Plant investigation has not yet been completed.A follow up report will be filled upon completion of the investigation.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 2637 shadelands dr.; walnut creek CA 94598
• Manufacturer Contact: dianne chin ; 920 winter st.; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4289339
• MDR Text Key: 5057487
• Report Number: 2937457-2014-03138
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• 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: 10/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: UNKNOWN SALINE; CUSTOMER COMBISET BLOOD LINE