Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.Device not returned.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) sticker was caught in the delivery device and could not be used.A replacement device was used to complete the procedure.The operation has been completed without any problems.
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Manufacturer Narrative
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Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure mode.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period sept 2019 through aug 2021 was reviewed.There were no triggers identified for the review period.Device not returned: (4114/ 3221/67) despite request and/ or customer indicated that the device would be returned; however, no device was returned.
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Event Description
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N/a.
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Search Alerts/Recalls
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