TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS DUAL COOLER HEATER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 11160 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the heater cooler knob was malfunctioning.As a result, the surgery was cancelled due to no available back up unit.
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Manufacturer Narrative
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The reported complaint was not verifiable.No analysis was performed since the unit cannot be serviced by the manufacturer and the customer cannot order replacement parts as the unit is at its end of service life.This complaint is related to (b)(4) mfr#1828100-2022-00189.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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