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 09/13/2017 |
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 healthcare professional (hcp) via a manufacturer's representative regarding a patient who was receiving morphine [35 mg/ml] at a dose of 23 mg/day via an implantable pump for non-malignant pain.It was reported on (b)(6) 2017 that the patient heard an alarm from the pump and after interrogation the patient¿s pump went from an elective replacement indicator (eri) of 39 months at the last refill (b)(6) 2017) to eri occurring on (b)(6) 2017.The pump was currently only three years old.It was noted as an environmental/external/patient factors that may have led or contributed to the issue that the patient was on a high daily dose of 23 mg/day.It was indicated that the pump was interrogated as diagnostics/troubleshooting performed and the logs were read and showed eri occurred.Surgical intervention did not occur but they were planning to replace the pump as soon as authorization was approved and that the pump would be sent back to the manufacturer for destructive analysis once replacement was scheduled.At the time of the report the issue was not resolved and the patient status was ¿alive ¿ no injury.¿ the patient medical history was asked and would not be made available due to a legal/confidential reason.The patient weight was asked and would not be made available due to a legal/confidential reason.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.The manufacturer's representative had no other information or pump printouts to provide.No further complications were reported or 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 a manufacturer's representative on (b)(6) 2017.The current and previous printouts were sent with the report.Pump settings that were examined on (b)(6) 2017(last change was (b)(6) 2017) showed that there was an estimated eri of 39 months and that the drug in the pump was ¿ms¿ (morphine sulfate) with a concentration of 35.0 mg/ml being delivered via simple continuous infusion mode at a dose of 23.181 mg/day.Pump logs that were examined on (b)(6) 2017 showed that eri occurred on (b)(6) 2017 (note this is conflicting with the pr evious report that eri occurred on (b)(6) 2017) with a schedule to replace the pump by (b)(6) 2017.No further complications were reported or anticipated.
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Manufacturer Narrative
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Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 manufacturer's representative (rep) on 2017-sep-20.It was reported that the pump was returned to the manufacturer for analysis.There were no further complications reported/anticipated.
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Manufacturer Narrative
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The pump was returned, and analysis found a feed through anomaly/shorting across the insulator.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected (b)(4) because, although the device meets design specification, corrective actions are focused on enhancements to the design making this the closest code available with respect to this event.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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