Device Problem
Failure to Infuse (2340)
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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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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No information has been provided to date.No product information has been provided to date.
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Event Description
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It was reported that the cassette was faulty.No patient injury was reported.
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Manufacturer Narrative
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Other, other text: b5: customer response june 24, 2022.Addition information received: patient information (initials, patient sex and dob), and operator of the device (patient).The event was reported during the use with the patient.The outcome was: resolved.Device is not available for investigation.Further information unknown.D5: correction: operator of the device: patient/consumer.
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Manufacturer Narrative
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H4: device manufacture date could not be completed due to lack of information regarding lot number.H10: device evaluation: the device was not returned for investigation, so no visual inspection and functional test were performed.Because no product was returned, the investigator was unable to confirm the reported complaint.If the product is returned however, the manufacture will reopen this complaint for further investigation.No lot number was provided; therefore, device history record review could not be completed.
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Search Alerts/Recalls
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