Model Number 816571 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The field service representative (fsr) was dispatched to the user facility.The fsr installed a new molded hinge molded on the 6 inch roller pump.The roller pump met manufacturer's specifications and was returned to clinical use.The fsr most recently replaced all the hinges at this user facility in (b)(6) 2016.This perfusionist is unhappy with the design of the lids and hinges on 6 inch roller pumps.
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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 lid had fallen off of the "yellow capped roller pump" in the operating room number 21.The perfusionist re-installed the lid and used the roller pump for the procedure.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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Evaluation is in progress, but not yet concluded.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis.The product surveillance technician (pst) installed and tested hinge on lab use only roller pump.The hinge functioned as intended.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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