Model Number BEQ-HLS 7050 USA |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).
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Event Description
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According to the customer: during patient treatment a hls 7.0 was making noise and decoupled.The hls 7.0 was replaced.No known consequences to the patient.(b)(4).
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Manufacturer Narrative
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Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- (b)(4).The returned hls set was investigated in the laboratory of the manufacturer on 2019-02-13.A visual inspection was performed and clots are detected in the pump and on the blood inlet side.A water cycle with the cardiohelp was performed and at the beginning a noise was heard , after that the pump continued run without any noise.The pump was removed from the hls module.All magnets are available and mounted in the correct way.The bearing ball is also available.Under the bearing ball a air inclusion was detected.No other abnormalities were detected.Thus the failure could be confirmed.The most probable root for the reported failure will be investigated in (b)(4).Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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Event Description
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Internal reference: (b)(4).
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Search Alerts/Recalls
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