This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.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.
|
It was reported that the device alarmed with a "no disposable" message twice.The second time user could not restart the device.She didn't realize infusion was off for 45 minutes until she got very sick (lightheaded, dizzy).Once the infusion was restarted, she felt better.There was no reported side effects from restarting at full dose.No patient injury was reported.
|