On (b)(6) 2021, the patient called medela llc (which becomes our aware date) and stated that he got an infection due to the pump not working.The pump was replaced by (b)(4), a medela distributor on (b)(6) 2021.(b)(4) was contacted by medela on 7/21/2021 for the return of the pump and was told it was not available for return.Medela is filing this report, which is considered a serious injury as it required medical attention.Also see related medwatch 1419937-2021-00061 and 1419937-2021-00062.
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On (b)(6) 2021, the patient contacted medela llc and alleged that the liberty negative pressure wound therapy pump was not working properly.The patient alleged that when you turn it on you get canister full message and signals that are not true.The patient alleged that there was no air leak but canister full message which goes off and on.The patient alleged that the wound bed was not sucked down, his dressing was changed yesterday and the blood in his wound hasn't moved.Medela customer service asked if he had contacted his doctor or wound care specialist he said no he contacted (b)(4), a medela distributor and they did troubleshooting with him last night and were sending out a replacement pump.The patient alleged that they played with the pump for a few hours while his nurse was with him.The patient also requested additional canisters to be sent to him and medela customer service said they would add that to his request.Medela customer service contacted (b)(4) with the customer's request and to asked (b)(4) to contact the customer on his order.
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