Model Number 16402 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The field service representative (fsr) was unable to verify the reported issue.He checked both fans to make sure they were okay, cleaned the roller pump motor brushes, and checked the pump calibrations and operation.The unit operated to the manufacturer's specifications.
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump turned in a jerking motion.As a result, an alternate device was employed.No other details regarding the nature of this event were provided.
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Event Description
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Per clinical review: on (b)(6) 2019, the team noticed a jerky rotation of their roller pump a few minutes prior to termination of the cardiopulmonary bypass (cpb) procedure.The roller pump in the arterial position was set up and primed with a 3/8 inch arterial raceway tubing boot.The occlusion was set according to hospital protocol.The jerky motion was noticed when they were at a lower speed when coming off bypass.The perfusion team noticed a knocking or thumping noise earlier in the procedure at a higher flow rate, but stated it was not evident that these two were related.The motion was it would spin as normal then kind of shimmy back and forth, then keep forward flow going.The team exchanged the roller pump after the patient was stable and off cpb.There was no harm or blood loss associated with the event.There was no delay in the continuation of the surgical procedure.
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Manufacturer Narrative
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Updated blocks: b5 and h6.
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Manufacturer Narrative
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Updated block: h6.The reported complaint could not be confirmed.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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