ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number 21-7300-24 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A product sample was received for evaluation along with three photographs.By reviewing the pictures, it was not possible to determine if the particulates observed were contaminants.During physical evaluation of the product, no contamination particles were found.The root cause is not able to be determined since the complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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Event Description
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It was reported that particulates were found in the cassette.No patient was involved.
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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 3012307300-2022-07866 is no longer considered reportable, please disregard any mdr reports associated with it.
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Search Alerts/Recalls
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