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

Model Number 190766

Device Problems Fluid/Blood Leak (1250); Inadequate Ultra Filtration (1656); Split (2537)

Patient Problem Hypovolemia (2243)

Event Date 12/28/2013

Event Type  Injury  

Event Description

The user facility reported that the dialysate tubing split open at the back of the machine about 1.5 hrs prior to the end of treatment.The machine continued to remove weight from the pt at a higher rate as the balancing chamber compensated for the fluid loss by pulling fluid from the pt.Too much fluid was removed from the pt over a short period of time and he subsequently loss consciousness for about six seconds.He appeared to be sleeping, with small spastic arm movements, and was unresponsive.A bolus of 350 ml of saline was given and the pt regained consciousness.There was no nausea and no "drs." the pt complained of being exhausted, but was alert and calm.His blood pressure was 101/76 and his pulse was 101.The pt stated he had felt dizzy and hot just before he lost consciousness, but there was no time for him to react.The physician was informed of the incident and paramedics arrived.The pt's blood pressure was 112/80 and his pulse was 87.He was transported to emergency and was ok.

Manufacturer Narrative

The pt's medical records are not available.A plant investigation is still in progress and a supplemental report will be submitted upon completion.

• Brand Name: FRESENIUS 2008T HEMODIALYSIS MACHINE
• 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 ; 7816999751
• MDR Report Key: 3641826
• MDR Text Key: 4287113
• Report Number: 2937457-2014-00179
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2014
• 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
• Patient Weight: 72