MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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Model Number 682000 |
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 09/19/2020 |
Event Type
malfunction
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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 [pm] set was found to be leaking fluid from the cable joints.The pm set was exchanged, and the procedure was successfully completed with no consequences to the patient.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
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Search Alerts/Recalls
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