Description of Event or Problem · 0
THE FOLLOWING HAS BEEN REPORTED: SERIAL NUMBER (B)(6), DEEP CLEANED MECHANISMS, LOADED CARTRIDGE, UNIT ATTEMPTED TO ROTATE DIAL AND FAILED. SEND TO DEPOT FOR REPAIR. RECEIVED AT DEPOT, CONFIRMED PUMP PROBLEM, STICKY PINS DUE TO SOIL BUILD UP, DEEP CLEAN SCREEN, CLEAN PINS AND MECHANISM, OPENED PUMP DEEP CLEANED, REPLACED LIP SEALS, RE HOMED AND GREASED RESISTOR MOTOR, PUMP PLACED IN BRING UP MODE AND SENT TO THE TEST LINE, PASS ALL STATIONS OF THE TEST LINE FRONT HOUSING, FINAL ACCEPTANCE, PROVISIONED PUMP TO 08 SERVER SENT TO HERATHERM, LOADED INTO HERATHERM @ 18.30 AND 04/12/2026, PASSED HERATHERM PULLED @ 06:30 04/13/2026, 24 HOUR DWELL - COMPLETE, LVP BURN-IN TEST - VALVE 2 FAIL 788 TIMES, NEEDS NEW PNEUMATICS SENT BACK TO REPAIR LINE, REPLACED FULL PNEUMATICS SYSTEM, PUMP PLACED IN BRING UP MODE AND SENT TO THE TEST LINE, PASS ALL STATIONS OF THE TEST LINE FRONT HOUSING, FINAL ACCEPTANCE, PROVISIONED PUMP TO 08 SERVER SENT TO HERATHERM, LOADED INTO HERATHERM @ 16:00 AND 05/01/2026, PASSED HERATHERM PULLED @ 04:00 05/02/2026, 24 HOUR DWELL - COMPLETE, LVP BURN-IN TEST - PASS, ACCURACY TEST - PASS, ELECTRICAL SAFETY TEST - PASS, PROVISION PUMP TO (B)(6), RETURN TO SERVICE, PROVISIONED PUMP, SOFTWARE UPDATE COMPLETE. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: UNDEFINED PNEUMATIC SYSTEM COMPONENT FAILURE. AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. THE DEVICE WAS REPAIRED BY THE CUSTOMER; FRESENIUS KABI IS COMMUNICATING THE INVESTIGATION AND REPAIR RESULTS HERE. FRESENIUS KABI WILL NOT BE RECEIVING THE DEVICE OR THE PARTS BACK FOR INVESTIGATION.