Catalog Number IAB-05840-LWS |
Device Problems
Difficult to Remove (1528); Communication or Transmission Problem (2896)
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Patient Problems
Injury (2348); Device Embedded In Tissue or Plaque (3165)
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Event Date 01/10/2019 |
Event Type
Injury
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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 the intra-aortic balloon (iab) zeroed prior to insertion then shortly after pumping a message fiber optic sensor (fos) signal weak and the pump switched to transducer waveform.The patient was stable using the transducer waveform.Additional information was received by the biomedical engineer.It was reported that the event occurred during removal of the iab.After the procedure was finished, the staff had difficulty removing the iab.As a result, the patient was sent to the operating room (or) to be "cut down", to remove the iab.There was no patient death reported.
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Event Description
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It was reported that the intra-aortic balloon (iab) zeroed prior to insertion then shortly after pumping a message fiber optic sensor (fos) signal weak and the pump switched to transducer waveform.The patient was stable using the transducer waveform.Additional information was received by the biomedical engineer.It was reported that the event occurred during removal of the iab.After the procedure was finished, the staff had difficulty removing the iab.As a result, the patient was sent to the operating room (or) to be "cut down", to remove the iab.There was no patient death reported.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab removal difficulty is not able to be c onfirmed.The root cause of the 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 revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
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Search Alerts/Recalls
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