Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump was found shut off, and no info about alarm available.It was reported that the cassette was changed on (b)(6) 2021 at 8pm, and when nurse came back on (b)(6) 2021 at 8pm, the pump was off for about 7hours (27 ml of medication found instead of 16ml.Flow rate 1,4ml/h).Reported that the nurse was able to switch the pump back on with no issue.It was reported that the patient experienced fatigue, shortness of breath, and leg pain.No additional adverse effects reported.
|
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
|