Catalog Number 397004-001 |
Device Problems
Difficult to Insert (1316); Mechanical Problem (1384)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to a patient because the driveline issue was observed when not supporting a patient.The companion drivelines will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
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Event Description
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The companion drivelines were not supporting a patient.The customer, a syncardia certified hospital, reported that during a training session, the companion drivelines were difficult to insert into several hand pumps.
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Manufacturer Narrative
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The hand pump and companion drivelines were not returned for evaluation; therefore, no investigation of the customer-reported issue of driveline insertion difficulty could be confirmed.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4282 follow-up report 1.
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Manufacturer Narrative
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The hand pump and companion drivelines were returned to syncardia for evaluation.Visual inspection revealed multiple areas of cosmetic damage to the body of the hand pump.The customer-reported issue was confirmed via the functional inspection when the hand pump was unable to connect to the returned drivelines or any other drivelines.The root cause was determined to be a bent cpc (colder products company) connector on the driveline connection of the hand pump and a bent cpc connector on the companion driveline's driveline connector.The cause of this damage cannot be conclusively determined, but is likely the result of a drop or other rough handling as evidenced by the noted cosmetic damage.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4282 follow-up report 2.
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Search Alerts/Recalls
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