Catalog Number 688410/B |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
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Event Date 08/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that during the hemodynamic monitoring of a patient, the pressure monitoring set was found to be leaking between the artery puncture needle and the safedraw connection.Blood was seen in the bed and clinician chose to give the patient a transfusion.No patient injury to report.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
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Search Alerts/Recalls
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