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Catalog Number 627257503 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Event date in unknown.Sorin group italia manufactures the smart perfusion pack.The incident occurred in new hyde park, new york, united states of america.Livanova is following up with the customer to identify if the disconnection occurred during procedure or was identified at the circuit set-up.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
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Event Description
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On (b)(6) 2022, sorin group italia received a medwatch mw5112038 that ecmo circuits are not connected at the bonded areas.Medical team have found a circuit that was supposed to have pre-bonded areas that is unconnected.There is no report of any patient injury.
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Manufacturer Narrative
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Livanova received a medwatch #mw5112038 stating that part of the ecmo circuit that was supposed to be pre-bonded, was unconnected.There is no report of any patient injury based on the few information provided on the mw, livanova interpreted the reported event as a disconnection from one of the 3/8¿x1/8¿ connectors in the bridge portion of the loop.Neither the involved device nor clarification on when the issue occurred, and length of time were provided.No picture was received.The dhr review confirmed the device was released conforming to product specifications.Review of the livanova complaint database identified a possible similar previous event related to another batching the complaints database another similar case on this pts pack code, but different lot number, occurred (refer to 1718850-2022-00055).According to the technical documentation of the complaint circuit item code, the involved connectors are secured using solvent.Livanova believed the event could be related to prolonged use in ecmo or to an incorrect assembly during pts manufacturing it shall be noted complaint circuit item code is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, not for ecmo.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Event Description
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See intial report.
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Search Alerts/Recalls
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