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 07/13/2017 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider via a manufacturer representative on (b)(6) 2017 regarding a patient receiving compounded baclofen (1100mcg/ml at 174.8mcg/day) via an implanted infusion pump.The indications for use included intractable spasticity and spinal cord injury/spinal cord disease.It was reported that the elective replacement indicator (eri) was occurring unexpectedly.The alarm was heard and confirmed by telemetry, and it was noted that the eri was premature.The event date was noted to be (b)(6) 2017.It was noted that the alarm was not silenced but it should be fine since the patient could barely hear it.The pump was reportedly still infusing as of the date of report.No patient symptoms were reported, and it was noted that they had a potential date to replace the pump on (b)(6) 2017.No further complications were reported or anticipated.
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Manufacturer Narrative
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Interrogation of the device revealed the pump had been programmed to deliver 1,150.0 mcg/ml of baclofen at 174.8 mcg/day.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The pump and catheter were returned to the manufacturer for analysis.It was indicated the reservoir was empty because the drug was transferred to the replacement pump at surgery on (b)(6) 2017.
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Manufacturer Narrative
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The pump was returned for analysis.During decontamination in the lab, a low battery reset occurred.Destructive analysis identified a high battery resistance during functional testing.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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