No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.
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It was reported that both legacy pumps were alarming no disposable alarms.Patient has mixed 2 new cassettes, with same results.Patient has troubleshot with no resolution.Patient reports previous issue with pump that caused him to receive more medication than programmed, states feet, mouth, hands felt weird.Patient able to resolve alarm with 3rd cassette mixed.2 affected cassette lot numbers: 4196398, expire: 2026-09-21.Patient off medication for 1 hour, asymptomatic.Patient will waste 3 partial cassettes, states has enough medication to last until next order.No further details provided.
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