TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
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Model Number 801041 |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/22/2016 |
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 set-up of the device for a cardiopulmonary bypass procedure, the roller pump display went in and out (blank).The user was still able to control using central control monitor (ccm) but changed out unit before case.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 not confirmed.During laboratory analysis, the reported complaint could not be duplicated.The product surveillance technician (pst) observed no blanking out of the display throughout testion conditions.Customer product was sent to service to be brought to manufacturers specifications before being returned to clinical use.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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