TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL
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Model Number 16402 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Per the user facility's biomedical technician, the problem occurred sometime in early (b)(6) 2019, but he does not know which date exactly.He determined that the speed pot assembly was the issue.
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Event Description
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It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump did not start rotating when set at a low speed.Once the speed was increased, the roller pump would immediately jump to the set speed.As a result, an alternate 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.The user facility's biomedical technician who is trained by the manufacturer has replaced the speed pot assembly.The unit operated to the manufacturer's specifications.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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