Catalog Number 394605 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that connecta plus3 red was damaged.The following information was provided by the initial reporter: the patient was admitted to the hospital on (b)(6) 2020 due to being unconscious by his family found for 40 minutes.Continuous blood purification was performed during hospitalization, and the connecta was broken during the treatment.
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Event Description
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It was reported that connecta plus3 red was damaged.The following information was provided by the initial reporter: the patient was admitted to the hospital on (b)(6) 2020 due to being unconscious by his family found for 40 minutes.Continuous blood purification was performed during hospitalization, and the connecta was broken during the treatment.
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Manufacturer Narrative
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H6: investigation summary a device history record review was completed by our quality engineer team for provided lot number 0006969.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Per the provided feedback of ¿connecta was broken during treatment,¿ the device can be broken due to incorrect use or incorrect connection.It is important to closely follow the instructions for use when handling the connecta product.See h.10.
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Search Alerts/Recalls
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