Model Number 5001102 |
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 03/15/2023 |
Event Type
malfunction
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Event Description
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The report states that the customer had an issue with product 5001102 during an aortic valve replacement.It was reported that contact between blood and circulating water while using mps2 on a patient.Blood purification was performed during extracorporeal circulation, and no adverse event occurred with the patient.The mps delivery set in question was discontinued and another circuit was used.
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Manufacturer Narrative
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Quest medical is continuing it's investigation.
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Manufacturer Narrative
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The suspect device was received by quest medical on 03/29/2023.Various tests were run to verify the presence of leaking in the disposable set at various pressure levels.The complaint condition could not be replicated.The disposable could not be confirmed as leaking and seems to have been functioning as intended.Quest medical has concluded its investigation of this device.Quest will continue to monitor complaint trends for this complaint condition.
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Search Alerts/Recalls
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