MAQUET HL-20 TWIN PUMP

Additional Manufacturer Narrative

(B)(4). THE FIELD SAFETY ENGINEER (FSE) PERFORMED THE UPDATE MCV/011/0002/IU ON 2 TPMS. THE FSE UPDATED SOFTWARE VERSION 1.4 TO VERSION 2.5. BASED UPON COMMUNICATION WITH THE SERVICE DEPARTMENT, THE VERSION 2.5 SOFTWARE WAS ONLY FOR RELEASE 11 TPMS, THE TPMS INVOLVED IN THIS EVENT WERE RELEASE 10. THE FSE WAS INSTRUCTED TO REINSTALL THE OLD, VERSION 1.4 SOFTWARE ON THE TPMS. REFERENCE: COMPLAINT (B)(4)

Description of Event or Problem

ON (B)(6) 2011, (B)(6), AN "ARTERIAL STOP" ERROR WAS RECEIVED ON TWIN PUMP MODULE (TPM) EN MED C (ARTICLE NUMBER: (B)(4)) WHILE BEING USED WITH HL20 5 PUMP CONSOLE (ARTICLE NUMBER: (B)(4)) THE ARTERIAL PUMP WORKS PROPERLY (E.G. 100 ROTATIONS/MIN), HOWEVER, THE CARDIOPLEGIA PUMP (IN SLAVE MODE) TURNS A QUARTER OF TURN, THEN STOPS, THEN TURNS A HALF A TURN, THEN STOPS, AND SO ON. THIS PROBLEM WAS OBSERVED AFTER THE FIELD SERVICE ENGINEER PERFORMED A SOFTWARE UPDATE ON THE TPM FROM VERSION 1.4 TO NEW SOFTWARE VERSION 2.5. A SECOND MDR WILL BE GENERATED FOR THIS EVENT SINCE TWO TWIN PUMP MODULE AND CONSOLE SERIAL NUMBERS ARE LISTED IN THE COMPLAINT. THE SECOND MDR # IS 8010762-2014-00504. REFERENCE: COMPLAINT (B)(4).