The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.Cardioquip was notified by the customer that there was patient involvement during the malfunction, although no information identifying the patient was provided.Upon initial investigation, cardioquip determined that the unit's water level sensor was improperly placed which allowed the system's main pump to operate without water in the line.The water level sensor was relocated to the correct location and all damaged components were replaced.Following the repairs, the device passed inspection and is fully operational.
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