Model Number 8637-40 |
Device Problems
Nonstandard Device (1420); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Analysis of the pump revealed over-infusion; undetermined root cause.Interrogation of the pump upon receipt indicated that the pump was used to infuse baclofen 2000mcg/ml at 360.5mcg/day.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 provider regarding a patient receiving compounded baclofen via an implantable pump.The pump was returned after prophylactic removal to avoid in-vivo battery depletion.There was no patient injury and no further complications were reported.
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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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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