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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RW40C
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
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).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, the reservoir clotted. The act was 625. The pump suckers were not used. 200 ml of washed cell saver blood was added to venous reservoir prior to bypass, then circuit was recirculated and the clotting occurred in the reservoir. No bank blood was added or used. Fluid level would continually drop and level alarm would go off (even with additional 200 ml plasmalyte added to circuit). The washed blood was from the surgeon harvesting the internal mammary artery. 20,000 units of heparin was put into the pump prime and no prime was removed from the cpb circuit. Oxygenator and reservoir changed out once the clotting was noted and unable to be corrected. This was not an emergency case. No consequence or impact to patient. The product was changed out. Procedure was completed successfully.
 
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Brand NameSTERILE FX15RWC W/ 4L 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 Key12053269
MDR Text Key261541992
Report Number1124841-2021-00146
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 distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX15RW40C
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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