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U.S. Department of Health and Human Services

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

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FRESENIUS MEDICAL CARE NORTH AMERICA RTG FRESENIUS 2008T MACHINE DIALYSIS MACHINE Back to Search Results
Model Number 2008T
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Cardiac Arrest (1762)
Event Date 10/10/2020
Event Type  Death  
Event Description
Hemodialysis pt attended regularly scheduled dialysis treatment. Pre vs 166/66, pulse 88, temp 98. 5. At approx 1246 dialysis initiated. At approx 1355 pt blood lines began clotting, hd tx interrupted. Patient's fistula needles were disconnected from both venous and arterial bloodlines. Both fistula needles were flushed and remained patent. A new dialysis system including both the combiset lines and f180nre optiflux dialyzer was to be set up and primed. Upon re-initiation of dialysis treatment, the venous line was reconnected to the venous needle and the arterial line was reconnected to the arterial needle. Hemodialysis treatment was re-initiated and blood pump was turned on. Within approx 2 minutes the patient reported pain at the venous needle site and then became unresponsive. Cpr and 911 was initiated. Ems arrived and took over care of the patient. Patient was transferred to hospital via ems. Subsequent inspection of dialysis lines, the venous line and dialyzer was noted to have visible air and no saline within the lines. The arterial line was noted to have visible saline present. The patient expired on (b)(6) 2020.
 
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Brand NameFRESENIUS 2008T MACHINE
Type of DeviceDIALYSIS MACHINE
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA RTG
waltham MA
MDR Report Key10801112
MDR Text Key215107174
Report Number10801112
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number2008T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2020
Distributor Facility Aware Date10/10/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/04/2020 Patient Sequence Number: 1
Treatment
BIBAG 1000ML NORMAL SALINE; COMBI TRUE FLOW BLOODLINES ; DIALYZER NRE OPTIFLUX ; FRESENIUS PRODUCTS - 2.0K, 2.5CA, 1.0MG, 100DEXTROSE (G2251)
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