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

Device Problem Inadequate Filtration Process (2308)

Patient Problem Hypervolemia (2664)

Event Date 07/06/2015

Event Type  Injury  

Event Description

During follow up for an unrelated event, the clinic manager (cm) reported a dialysis machine did not remove the fluid volume it was set to remove.The patient required an additional treatment to remove the fluid.No further medical intervention was required.The cm did not have any specific details and additional information regarding the product serial number and / or treatment information.

Manufacturer Narrative

Requested information has not yet been received.The plant investigation is in progress.A supplemental medwatch will be submitted.

Manufacturer Narrative

Despite multiple attempts for follow up information, none has been received.No serial number, repair, or machine status has been provided.The complainant facility was unable to provide a sample for evaluation.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.The complaint is not confirmed.Treatment records and patient information were requested but not received.

• Brand Name: 2008K HEMODIALYSIS MACHINE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham , MA 02451 ; 8006621237
• MDR Report Key: 4941940
• MDR Text Key: 6035601
• Report Number: 2937457-2015-01285
• Device Sequence Number: 1
• Product Code: KDI
• 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: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• 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?: Yes
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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