At about 35 minutes into a case, the patient temperature stopped cooling at 19.2 degrees.The case required 18 degrees for circulatory arrest.After 30 minutes of trying to troubleshoot, ice was added directly into the tank in order to cool the patient.Rewarming the patient was also difficult.No patient injury reported.(b)(4).
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Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(4).A field service technician was onsite for further investigation.According to the service report# 42839719 dated on 2018-11-30 following was found: the field service technician (fst) downloaded the log files and recorded two hours run-time log of device to be reviewed by maquet support team.The hospital told that they never descaled the unit.The unit was installed in 2017.According to the hcu 40 ifu, the deescalation procedure should be performed every three months.The fst cleaned the ice sensors.The fst could not reproduce the reported issue.After consulting the maquet support team, the fst checked mixing, shunt and vacuum valves.Mixing valve and vacuum valve were replaced (and are handled in complaint# (b)(4) and (b)(4)).The fst completed the inspection with no errors.The unit is cleared for clinical use.Since the fst could not duplicate the issue, the failure could not be confirmed.Most probable root cause could be determined as user error, since the unit has never been descaled.
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