MAQUET VARIO TWIN, HL 20, 4-PUMPS

Description of Event or Problem

IT WAS REPORTED THAT THE DURING SELF TEST SINGLE ROLLER PUMP MOVING HIGH SPEED AND SHOWING ERRORS SAFETY S AND RUN AWAY. THE SAFETY-S ERROR REFERS TO A FAILURE REGARDING A RECURRING DEVIATION BETWEEN THE MEASURED AND SET VALUE OF THE PUMP SPEED OF AT LEAST 10%. EXAMPLE: THE PUMP SPEED IS SET WITH 1000 ROUNDS PER MINUTES (RPM) AND THE ACTUAL SPEED IS MEASURED ON THE PUMP HEAD WITH GREATER THAN 1100 RPM. IN ORDER TO PROTECT THE PT FROM EXCESSIVE PUMP SPEED, AN AUTOMATIC PUMP STOP IS GENERATED TOGETHER WITH THE SAFETY-S ERROR. IN ORDER TO RESTART THE PUMP, THE USER HAS TO FOLLOW THE INSTRUCTIONS IN THE USER MANUAL. NO KNOWN CONSEQUENCES TO THE PT. NO FURTHER INFO HAVE BEEN PROVIDED TO THE MFR. (B)(4).

Additional Manufacturer Narrative

MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE, MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. FIELD SAFETY TECHNICIAN CHECKED THE UNIT AND FOUND THE PROBLEM ON THE MOTOR CONTROL BOARD, WHICH NEEDS TO BE REPLACED. FIELD SAFETY TECHNICIAN CHECKED WITH ANOTHER PUMP PARTS AND TESTED AND FOUND THAT MOTOR CONTROL BOARD WAS DEFECTIVE. PART HAS TO BE REPLACED AGAINST WARRANTY.