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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET TRUE FLOW SERIES HEMODIALYSIS BLOOD TUBING SET
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FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET TRUE FLOW SERIES HEMODIALYSIS BLOOD TUBING SET Back to Search Results
Catalog Number 03-2722-9
Device Problems Failure To Adhere Or Bond (1031); Connection Problem (2900)
Patient Problems Cardiopulmonary Arrest (1765); Hypovolemia (2243); Blood Loss (2597)
Event Date 12/06/2017
Event Type  Death  
Event Description
Approximately 2.25 hours into a scheduled 3 hour hemodialysis treatment, patient was found non-responsive.Most recent vs (10 minutes prior): b/p 141/54, pulse 98.The venous line was noted to be disconnected with hemaclip still in place.The venous bloodline and cvs venous line were clamped.The blood pump was stopped.Patient was placed on left side, oxygen applied and 911 called.Aed was applied; cpr was initiated.A total of 400 ml normal saline was infused; two shocks administered with aed.Patient was transported to the hospital via ems where she later died.
 
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Brand Name
COMBISET TRUE FLOW SERIES HEMODIALYSIS BLOOD TUBING SET
Type of Device
HEMODIALYSIS BLOOD TUBING SET
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
renal therapies group
waltham MA
MDR Report Key7154225
MDR Text Key96127866
Report Number7154225
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 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Catalogue Number03-2722-9
Device Lot Number17KR01047
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2017
Distributor Facility Aware Date12/06/2017
Event Location Outpatient Treatment Facility
Date Report to Manufacturer12/14/2017
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;
Patient Age75 YR
Patient Weight39
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