Model Number N/A |
Device Problems
Calibration Problem (2890); Device Operates Differently Than Expected (2913)
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Patient Problem
Cardiopulmonary Arrest (1765)
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Event Date 05/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) evaluated the iabp and performed running test in getinge office, and the reported incident was not duplicated.The iabp worked normally and all functional and safety tests were passed per factory specifications, thus no parts were replaced.The iabp was returned to the customer and has been released for clinical use.
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Event Description
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It was reported that after the intra-aortic balloon (iab) was inserted into a cardiopulmonary arrest patient, the optical sensor was unable to take the arterial pressure since the catheter was located in the patient.Although attempts were made to connect it with the sensor connector, it was unable to take a calibration.The cardiosave iabp was replaced with a cs100 to continue therapy; however, the arterial pressure was unreadable.The surgeon had an impression of the catheter failure, and used the monitor kit from another line to measure arterial pressure instead of the optical sensor.Three days later they removed the iab and discontinued iabp therapy.No patient harm or adverse event was reported.
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Manufacturer Narrative
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Correction of date in initial mdr: please note that the date in the initial mdr was erroneously reported as (b)(4) 2018 but should read (b)(4) 2018.
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Event Description
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It was reported that after the intra-aortic balloon (iab) was inserted into a cardiopulmonary arrest patient, the optical sensor was unable to take the arterial pressure since the catheter was located in the patient.Although attempts were made to connect it with the sensor connector, it was unable to take a calibration.The cardiosave iabp was replaced with a cs100 to continue therapy; however, the arterial pressure was unreadable.The surgeon had an impression of the catheter failure, and used the monitor kit from another line to measure arterial pressure instead of the optical sensor.Three days later they removed the iab and discontinued iabp therapy.No patient harm or adverse event was reported.
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Search Alerts/Recalls
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