Model Number HST III SYSTEM (3.8MM) |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Event Description
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Related to (b)(6).The hospital reported that the hst iii system (3.8mm) blocking umbrella is disengaged from the conveying device.It was found during the loading process that the blocking umbrella was not loaded into the delivery pipe.Replaced the same equipment to complete the surgery.No harm to the patient.
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Manufacturer Narrative
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Trackwise # (b)(4).The lot # 25160137 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.It is not possible to confirm the reported complaint.
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Search Alerts/Recalls
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