Model Number 8637-20 |
Device Problem
Contamination (1120)
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Patient Problem
Pocket Erosion (2013)
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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 healthcare provider (hcp) via a manufacturer representative on (b)(6) 2020 regarding a patient receiving morphine (10mg/ml at 0.940mg/day) via an implanted infusion pump.The indication for use was non-malignant pain.It was reported that the patient's pump was being replaced.There was nothing wrong with the old pump, but the hcp wanted to replace it because the patient had erosion at their skin and the pump was showing through.The hcp believed the pump was then contaminated since the area the erosion occurred was at a wound site.The pump was being replaced and moved to the other side of the abdomen.The patient's personal therapy manager (ptm) handset was decoupled from the old pump to the new pump.No other symptoms were reported and 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 received from the manufacturer representative (rep) reported the pump was explanted on (b)(6) 2020.
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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 via a company representative.The pump was discarded by the hospital and therefore would not be returned.
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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 the manufacturer representative (rep).The rep believed the device would be returned to the manufacturer.
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Search Alerts/Recalls
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