Catalog Number IAB-05840-LWS |
Device Problems
Device Alarm System (1012); Communication or Transmission Problem (2896); Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/20/2017 |
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 the rn called the clinical support specialist (css) and stated they had a patient on bypass and they were having trouble getting the pump up and running.The rn stated the fiber optic sensor (fos) was connected and the bulb was green.The rn was slaving the electrocardiogram (ecg) from the anesthesia monitor.The arterial pressure was flat.The css had her change the pump back to autopilot and disconnect the ecg cable.The rn stated the flashing heart was irregular and the pump would only pump intermittently.The css explained that they were having triggering issues and discussed possible causes.During the discussion, the surgeon removed the balloon and asked for another one.Patient outcome: meeting goals of therapy.There was no reported death or serious injury to the patient.There was a report of delay in therapy but no complications caused to the patient.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of triggering issues is not able to be confirmed.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.The reported complaint will be monitored for developing trends.
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Event Description
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It was reported the rn called the clinical support specialist (css) and stated they had a patient on bypass and they were having trouble getting the pump up and running.The rn stated the fiber optic sensor (fos) was connected and the bulb was green.The rn was slaving the electrocardiogram (ecg) from the anesthesia monitor.The arterial pressure was flat.The css had her change the pump back to autopilot and disconnect the ecg cable.The rn stated the flashing heart was irregular and the pump would only pump intermittently.The css explained that they were having triggering issues and discussed possible causes.During the discussion, the surgeon removed the balloon and asked for another one.Patient outcome: meeting goals of therapy.There was no reported death or serious injury to the patient.There was a report of delay in therapy but no complications caused to the patient.
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Search Alerts/Recalls
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