Model Number 8637-40 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 health care professional via a company representative regarding a patient who was receiving baclofen (concentration (2000 mcg/ml, dose 725 mcg/day) via an implantable pump for cerebral palsy and intractable spasticity.A critical alarm was heard and confirmed by telemetry on the day prior to this report date, the alarm was due to elective replacement indicator (eri) and was not expected because at the last refill on (b)(6) 2016\, the eri was at 16months.There were no symptoms reported.
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Event Description
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Additional information was received from a healthcare provider.It was stated at the refill on (b)(6) 2016 the pump was refilled and the dose was increased.A pump interrogation took place and showed an elective replacement indicator (eri) alarm event.It was stated that a pump replacement was scheduled for (b)(6) 2017.At the time of the report the issue was not resolved and it was not determined what caused the premature eri.
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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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