Model Number 801041 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.
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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 was dead.As a result, an alternative device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the guts to be seized.The pump was placed in the forward direction and speed was slowly increased.There was no gut rotation due to a seized main bearing.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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Event Description
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Per clinical review: multiple diligence attempts were not successful in obtaining additional information.During a bypass procedure on (b)(6) 2018, the roller pump stopped working.It is not known at this point if there was alarm notifications or what type of tubing or location the pump was operating in.The perfusionist on the case did exchange the roller pump with another roller pump during the procedure.The incident did not stop or delay the continuation of the surgical procedure.There was no blood loss, nor harm associated with the event.
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Manufacturer Narrative
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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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