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Model Number IPN000320 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
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Event Description
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It was reported by the field service representative (fsr) that the staff were getting ready to put the reported intra-aortic balloon pump (iabp) on the patient but weren't able to get the iabp working.The staff stated the unit displayed a message to check tubing, helium, trigger, and valve malfunction.As a result, the staff swapped the iabp with another one and were able to put it on the patient.There was a report of patient death; however, the cath lab nurse (b)(6) confirmed that the device did not cause or contribute to the patient's death.
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Manufacturer Narrative
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(b)(6).Teleflex received the device for investigation.The reported complaint of "valve error" is not confirmed.The returned pcs assembly passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial 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 revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported by the field service representative (fsr) that the staff were getting ready to put the reported intra-aortic balloon pump (iabp) on the patient but weren't able to get the iabp working.The staff stated the unit displayed a message to check tubing, helium, trigger, and valve malfunction.As a result, the staff swapped the iabp with another one and were able to put it on the patient.There was a report of patient death.However, the cath lab nurse gary campbell confirmed that the device did not cause or contribute to the patient's death.
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Search Alerts/Recalls
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