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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX15RW30
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
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. For this reason, terumo references evaluation conclusion code (b)(4). Component code #1: (b)(4): reservoir. Component code #2: (b)(4): filter. Health effect: impact code: (b)(4) no patient involvement. Health effect: clinical code: (b)(4): no clinical signs, symptoms or conditions. Medical device problem code: (b)(4): coagulation in device or device ingredient. Investigation findings: (b)(4): results pending completion of investigation. Investigation conclusions: (b)(4): conclusion not yet available.
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the oxygenator reservoir got clot while priming with blood. De-foaming chamber and screen filter of reservoir got clot resulting in decrease of dynamic volume ( level) while circulating and air came in the circuit. As per the clinical specialist, additional information form the facility states that, 1 unit of blood were put into the reservoir and a blood filter was used in the units of blood when it was put into the reservoir. It is unknown as to what the level of anticoagulation was of the blood introduced to the reservoir and how much heparin was put in the pump prime. Blood is going to clot whenever is contacts any foreign surface if it is not adequately anticoagulated. *no patient involvement *product was changed out prior to cpb during blood priming *procedure was completed successfully.
 
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Brand NameHOLLOW FIBER OXY WITH 3000 ML
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 Key12452724
MDR Text Key270812756
Report Number1124841-2021-00214
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450127
UDI-Public(01)00699753450127
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*RX15RW30
Device Catalogue NumberN/A
Device Lot NumberYA20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2020
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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