Model Number 8637-20 |
Device Problems
Electromagnetic Interference (1194); Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2017 |
Event Type
Injury
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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 health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for intractable spasticity and multiple sclerosis.The pump contained an unknown brand of baclofen with an unknown concentration and dose.It was reported the patient recently had an mri and experienced a motor stall on (b)(6) 2017 that had not recovered as of the day of report.The representative was going to have the hcp check the logs again to see if a motor stall recovery was noted in the logs.No patient symptoms/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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Event Description
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Additional information was received from a healthcare professional (hcp) via a company representative.It was unknown if any alarms were heard from the pump.It was unknown what interventions were done to resolve the motor stall.The patient was referred to a surgeon for a replacement consultation.It was unknown if the issue was resolved.The patient¿s weight at the time of the event was unknown.The provided information has been confirmed with the physician.
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Manufacturer Narrative
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Evaluation of implantable pump serial number (b)(4) did not reveal any anomalies.The returned pump passed all functional testing in the lab.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Interrogation of the device revealed the pump had been programmed to deliver 250.0 mcg/ml of baclofen at 38.02 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 was returned to the manufacturer for analysis.
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Manufacturer Narrative
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No longer applicable to this case.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 consumer via a device manufacturer representative.The pump's motor stalled on (b)(6) 2017 after an mri, per the pump logs.A tube set message occurred on (b)(6) 2017.During a refill on (b)(6) 2017 the motor stall recovered.The pump was replaced on (b)(6) 2018.The issue was considered resolved at the time of the report.The patient's status at the time of the report was alive - no injury.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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Event Description
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Additional information received from a manufacturer representative indicated a motor stall recovery occurred when the pump was interrogated on (b)(6) 2017.There was no unusual discrepancy observed.It was noted the pump had already been turned down prior to interrogation.It was further stated there was reason to believe the pump was delivering medication following the mri on (b)(6) 2017.However, the health care provider (hcp) was nervous and had the patient referred for replacement.
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Search Alerts/Recalls
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