Catalog Number 50000000E |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that biomed received the unit and while filling noticed it was leaking, they pulled the cover off it and found the leak was came from the chiller pump.Device was came back for service.
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Manufacturer Narrative
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The reported issue was unconfirmed.The root cause was not able to be isolated as the reported issue was unconfirmed.The device was evaluated and the reported issue was not duplicated during testing as no leaks were observed.The reported issue was unconfirmed and not a manufacturing or supplier related failure.Dhr review not required.The reported event is unconfirmed, labeling/packaging review is not required.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that biomed received the unit and while filling noticed it was leaking, they pulled the cover off it and found the leak was came from the chiller pump.Device was came back for service.
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Search Alerts/Recalls
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