Catalog Number 0998-00-0800-53 |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the drive transducer.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had an autofill error during a training session.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 12 month product complaint trend data for the period (feb 2020 through jan 2021) was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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