Model Number 16402 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The field service representative (fsr) ran the roller pump several minutes with tubing but was not able to verify the reported complaint.He replaced the drive motor belt as a precaution.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.
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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 pump had a belt slip error.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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Updated blocks: b5: event and h6.The reported complaint could not be confirmed.During laboratory analysis, the product surveillance technician (pst) observed the belt to operate as expected when at optimal and over occluded conditions.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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Additional information was received that an alternate device was employed.
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Search Alerts/Recalls
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