Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problems
Crack (1135); Premature Activation (1484); Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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.
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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) seal was bent inside.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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H6 correction: device codes changed to "crack".Internal complaint number: (b)(4).Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was inside the loading device.The loading device was observed to be intact, no visual defects were observed.Due to the positing of the device in the photograph it is unclear if the white plunger is fully depressed or the position of the blue slide lock.The seal was observed in the loading device window.The seal was observed to be in a semi taco shape with no visual defects observed.The device was returned on (b)(6) 2020.An investigation was conducted on (b)(6) 2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned outside the loading device.The loading device case was observed to be in two pieces indicating break.We are unable to determine when the splitting of the case occurred based on the photographs provided by the account and investigation.The seal and tension spring assembly was observed to be inside the delivery device but not properly loaded.The white plunger was not depressed and the blue slide lock was not dis-engaged.The seal and tension spring assembly was removed from the delivery device.No visual defects, cracks or delamination was observed on the seal.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.197 inches, the outer diameter was measured at 0.219 inches.The length of the delivery tube was measured at 2.50 inches.The values recorded were within the tolerance specifications.Based on the returned condition of the device, the reported failure "crack seal" was not confirmed; however, the analyzed failure modes "break" and "fitting problem" were confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.
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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) seal was bent inside.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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