ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number 21-7302-24 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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No product sample was received; therefore, visual and functional testing could not be performed.A device history record review was performed, and no issues were noted during manufacture.No root cause could be determined as the complaint could not be confirmed.
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Event Description
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It was reported that the bag inside the cassette was leaking.No patient was involved.
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Manufacturer Narrative
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While performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.File (b)(4) is no longer considered reportable, please disregard any mdr reports associated with it.
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Manufacturer Narrative
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Other, other text: while performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-07765 is no longer considered reportable, please disregard any mdr reports associated with it.
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Search Alerts/Recalls
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