Model Number CAR-500 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The cartridge was not received for evaluation.A device history record (dhr) review was conducted for the reported lot number and revealed the product was released for distribution having met quality and manufacturing specifications and requirements.The instructions for use states "make sure mated luer-connectors are secure but do not over-tighten, especially when connections are wet".
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Event Description
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A report was received on (b)(6) 2020 from the nurse of a critical care patient with unspecified pathology, who stated the cartridge venous line luer broke within the patient's central venous catheter (cvc) during a continuous renal replacement therapy (crrt) treatment on (b)(6) 2020, there was no indication of adverse impact to patient and no report of medical intervention being required.
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Manufacturer Narrative
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Analysis of this event by quality engineering confirmed that the product design prevents any risk to patient safety should the connector failure recur as reported by the customer.
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Search Alerts/Recalls
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