This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.Additional information provided in h6.The device history report (dhr) review is not applicable or relevant because no product was returned and thus an investigation could not be performed.No product sample was received; therefore, visual and functional test could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.No product was returned however the pumps operators manual advises that the entire operator's manual should be read before operating the pump.Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient, and/or damage to the pump.At this point there is no evidence that the pump failed to meet specifications.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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