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.
|
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.
|