Model Number 102956 |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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The motor is not a single use device.Approximate age of the device will be provided with the results of the device analysis.The device is expected to be returned for evaluation.It has not yet been received no further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
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Event Description
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It was reported that during testing of the system, a motor disconnected alert occurred whenever the pump motor was moved up or down.There was no patient involvement with this event.The motor will be returned to the manufacturer for evaluation.No additional information was reported.
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Event Description
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It was reported that during testing of the system, a motor disconnected alert occurred whenever the pump motor was moved up or down.There was a concern for about a motor cable issue.The motor will be returned to the manufacturer for evaluation.There was no patient involvement with this event.No additional information was reported.
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Manufacturer Narrative
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It was noted that information was inadvertently omitted from the initial submission."there was a concern for about a motor cable issue." has been added to the event problem.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the reported event was confirmed through the evaluation of the returned centrimag motor.The returned centrimag motor was evaluated by abbott technical services personnel.While running the system, the reported complaint was able to be duplicated with manipulation of the motor cable.The pump started crashing and a motor connection error was displayed.These failures were consistent with the preliminary findings of the product performance engineering team during electrical continuity testing of the motor cable upon receipt of the unit, which found an intermittent open connection in the cable line when bending the cable near the motor housing.The evaluation deemed the unit defective and the centrimag motor was scrapped.A capa has been initiated to further investigate the issue of breakdown in centrimag motor cables.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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