Model Number 816571 |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The field service representative (fsr) could not duplicate the reported complaint.The fsr replaced the roller pump and release testing was performed.The unit operated to the manufacturer's specifications.
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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 roller pump displayed a 'service pump' message.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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During laboratory analysis, the product surveillance technician (pst) observed the pump to function as intended.With the pump connected to lab use only (luo) testing equipment, no unexpected errors occurred.The pump was run for several hours with no disruptions observed.The reported complaint could not be duplicated, and it was determined that the unit operated as intended.
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Manufacturer Narrative
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The reported complaint was confirmed.Per the service repair technician (srt) there was some wear found on the upper shaft of the pump and a damaged snap ring which was a possible cause of the reported complaint.The snap ring was replaced.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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Manufacturer Narrative
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The device was manufactured prior to the udi labelling effectiveness date, and therefore does not contain a udi label, but the applicable udi information associated with the device is (b)(4).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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