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Catalog Number IAP-0701 |
Device Problems
Loose or Intermittent Connection (1371); Failure to Read Input Signal (1581)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that when the fos catheter was inserted into patient and the intra-aortic balloon pump (iabp) started, it was noted that the helium and battery icon both had crosses on them.No ecg, ap, and balloon waveform detected on the iabp.As a result, the pump was swapped out.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.When the engineering team check the equipment, it was noted that the communication cable connection between front end board and cpm board was loose and its "hook" that was supposed to secure the connection was not securing it.The pump was working fine after all connections was secured.
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Event Description
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It was reported that when the fos catheter was inserted into patient and the intra-aortic balloon pump (iabp) started, it was noted that the helium and battery icon both had crosses on them.No ecg, ap, and balloon waveform detected on the iabp.As a result, the pump was swapped out.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.When the engineering team check the equipment, it was noted that the communication cable connection between front end board and cpm board was loose and its "hook" that was supposed to secure the connection was not securing it.The pump was working fine after all connections was secured.
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Manufacturer Narrative
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(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of red x's on helium and battery icons and no patient signals is confirmed.A field service technician serviced the pump and found a loose cable connection between the cpm and feb boards, which is the suspected cause of the complaint.The root cause of this complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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