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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25REC
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there is evidence of a cut in the line during the assembly that gives continuity to the manifold line, making it impossible to use. No patient involvement. Product was changed out. Procedure was completed successfully with at least 3 minutes delay.
 
Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4).
 
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Brand NameSTERILE FX25REC W/RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer (Section G)
SAME
Manufacturer Contact
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key13003385
MDR Text Key286868979
Report Number1124841-2021-00275
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberZH26
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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