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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number 03-2630-6
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  malfunction  
Event Description
The connection between arterial tubing and saline tubing on the hemodialysis blood tubing set was suddenly detached during priming of the dialysis machine.Fresenius combi hemodialysis tubing set.Lot number: 21sr01044 exp date: 12/31/2024.
 
Event Description
The connection between arterial tubing and saline tubing on the hemodialysis blood tubing set was suddenly detached during priming of the dialysis machine.Fresenius combi hemodialysis tubing set.Lot number: 21sr01044 exp date: 12/31/2024.
 
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Brand Name
FRESENIUS COMBI SET
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
920 winter street
waltham MA 02451
MDR Report Key13771756
MDR Text Key287210164
Report Number13771756
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03-2630-6
Device Catalogue Number03-2630-6
Device Lot Number21SR01044
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/02/2022
Event Location Hospital
Date Report to Manufacturer03/15/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/15/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/17/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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