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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE COMBI SET TRUE FLOW SERIES
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FRESENIUS MEDICAL CARE COMBI SET TRUE FLOW SERIES Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)
Patient Problems Cardiac Arrest (1762); Death (1802); Exsanguination (1841)
Event Date 08/26/2017
Event Type  Death  
Event Description
Hemodialysis pt arrived for regular scheduled treatment.Pre bp 139/71, pulse 69, temp 96.4, resp 16.Hemodialysis initiated at approx 0705 via right tunneled jugular catheter.At approx 0900 bp 95/50, pulse 69.At approx 0915 pt was found unresponsive, blood leaking between the arterial connector of the pt's arterial tunneled catheter and the arterial portion of the combiset dialysis lines.Cpr was initiated and 911 was called.Pt was transported to hospital and expired in the er.
 
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Brand Name
COMBI SET TRUE FLOW SERIES
Type of Device
COMBI SET TRUE FLOW SERIES
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
waltham MA 02451
MDR Report Key6875204
MDR Text Key86919996
Report Number6875204
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2017
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2017
Distributor Facility Aware Date08/26/2017
Device Age1 NA
Event Location Other
Date Report to Manufacturer09/08/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
Patient Age84 YR
Patient Weight83
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