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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3ZZ*FX25RECA
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
Terumo has received the device for evaluation; however, 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 oxygenator clotted in the sock of the reservoir. As per the clinical specialist, an information was provided by the chief of perfusionist stating that, during the pre-bypass phase of the procedure, recirculating volume was noted in the cardiotomy filter area of the venous reservoir. The perfusionist performing the procedure called the chief perfusionist into his room to consult on the situation. The filtration media was challenged by adding additional crystalloid via the rapid prime port. It was observed that the additional prime volume added to the circuit was not flowing into the venous reservoir at an expected rate of flow. This indicated to the team that the depth media was occluded. The product had to be changed out. No impact to procedure or patient. This occurred after the pump suctions were initiated and blood was entrained from the field. According to the chief of perfusionist, the surgeons are always pressuring the perfusion team to initiate the pump suctions to recover the blood loss created during cannulation. He also stated that the act¿s were probably on the lower edge of acceptability. The actual act value is unknown. The product was changed out. There was a minimal blood loss. Procedure was completed successfully.
 
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Brand NameNS 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 Key11913102
MDR Text Key260481201
Report Number1124841-2021-00125
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 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3ZZ*FX25RECA
Device Catalogue NumberN/A
Device Lot NumberYL14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2020
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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