Model Number 8637 |
Device Problems
Failure To Service (1563); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp), via a manufacturer¿s representative (rep) regarding a drug infusion device.The drug being delivered was 500 mcg/ml baclofen (unknown) at 150 mcg/day.The reason for use was not reported.It was reported that the patient missed a refill.The rep received a call stating that the patient¿s refill date was supposed to be on (b)(6) 2018.An empty pump was reported and the caller did not have access to the patient or an 8840 clinician¿s programmer.¿the caller did not confirm an empty reservoir alarm, but based on the missed refill date and the programming they suspect the pump is empty.¿ empty pump considerations and catheter/tubing patency/damage considerations were reviewed.The caller asked about intrathecal to oral conversion and it was reviewed that there is no known conversion.The patient information and physician information was unknown.There were no symptoms reported.There were no further complications reported/anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the rep on (b)(6) 2018.It was reported that the doctor did a refill 2 days later, on (b)(6) 2018.The rep was unaware of the patient¿s name.The rep had no further information regarding the event.There were no further complications reported/anticipated.
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Search Alerts/Recalls
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