It was reported that per medwatch (b)(4) spontaneous call from patient.Spoke to patient she is still experiencing some headaches, jaw pain and diarrhea.Says her medical doctor is aware of this, and the side effects are tolerable.Advised patient if the side effects become worse or new side effects occur to let us and the medical defense officer know.Patient understood.Patient did have an issue with a cassette approximately a week ago.The reported product fault did occur while in use with a patient.The product issue did not cause or contribute to patient or clinical injury.The event is resolved.This incident has happened within the past 6 months.This patient has reported a pump malfunction within the past 6 months.Patient had her pump replaced recently.Her husband drew up another mix and replaced the cassette and the issue resolved.Patient is doing well.Patient did not save cassette.Patient unsure of exact type of alert, just that it was a no disposable.Alert no other info/dates provided.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual cassette available for investigation? no.Did we replace the cassette? she is ordering refill today.Did the patient have additional cassettes they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life sustaining? yes.What is the outcome of the event? resolved.Reported to, by patient caregiver.
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Other, other text: h6: event problem and evaluation codes: updates not required.H10: the device was not returned for investigation for the reported issue; no visual inspection and functional test were performed.Based on the fact that no product was returned, the investigation was unable to confirm the reported complaint.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.
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