Information was received from a healthcare provider (hcp), consumer, and a company representative regarding a patient receiving sufentanil (360 mcg/ml at 160 mcg/day), bupivacaine (32 mg/ml at 14.2 mg/day), and clonidine (300 mcg/ml at 133.44 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.It was reported that the patient noticed an area around the pump that was becoming more sensitive, and the skin was less protective, but didn¿t come into the hospital until this past weekend ((b)(6) 2022) despite the hcp requesting sooner for evaluation.The pump was dehisced/the corner had eroded through the skin and it was infected.The infection started a couple of months ago with just some redness near the pump site.From there, the infection progressed culminating in pump replacement.The pump was explanted on (b)(6) 2022, and a new pump was implanted in a new location on the same side to avoid full explant and ensure the incision closed.The patient had some minor swelling as of (b)(6) 2022.With regards to any environmental, external, or patient factors that may have led or contributed to the issue, it was noted that the patient had no falls or other reported issues.The issue was noted to be resolved.It was indicated that the hcp had no further information to provide regarding the event.
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