Model Number BO-HBF 140-J |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2018 |
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 the leak test (@100kpa) , the leakage was detected on 2 products." no known consequences to the patient was reported.(b)(4).
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Event Description
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Ref.: # (b)(4).Customer ref: # (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 ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).The product has been received at maquet for investigation.According to the investigation report following tests have been performed: leak test and test with connection to water cycle incl.Flow- and pressure-measurement.During both tests 2 leakages at the connection of the housing and the cover were detected: leaking point at the de-airing port and at the white bypass port.Thus the failure could be confirmed.Most possible root cause could be determined as bad welding between cover and housing of the quart filter.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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Search Alerts/Recalls
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