Model Number MX493 |
Device Problems
Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2022 |
Event Type
malfunction
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Event Description
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It was reported via medwatch number (b)(4): patient stated that they noticed wetness in the black bag containing solution bag and pump.No patient injury or adverse affects were reported.
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Manufacturer Narrative
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The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
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Manufacturer Narrative
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No lot number was provided; therefore, device history record review could not be performed.D5 is the patient/consumer.
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Search Alerts/Recalls
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