BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 2035632 · Received March 31, 2011

    Report

    Report Number
    9611451-2011-00207
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Report Date
    March 3, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). LOT NUMBER: 081118, QUANTITY: 1, DATE OF MANUFACTURE: 18 NOVEMBER 2008; 100601, 1, 1 JUNE 2010; 100706, 2 , 6 JULY 2010; 100804, 4, 4 AUGUST 2010; 100816, 1, 16 AUGUST 2010; 101004, 1, 4 OCTOBER 2010. THE COMPLAINT CIRCUITS HAVE RECENTLY BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). LOT NUMBER: 081118, QUANTITY: 1, DATE OF MANUFACTURE: 18 NOVEMBER 2008; 100601, 1, 1 JUNE 2010; 100706, 2, 6 JULY 2010; 100804, 4, 4 AUGUST 2010; 100816, 1, 16 AUGUST 2010. NARRATIVE: METHOD: EIGHT COMPLETE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION. THE FOLLOWING COMPONENTS OF DEVICE #9 WERE RETURNED: TWO DRY LINES AND ONE MR290 AUTOFEED HUMIDIFICATION CHAMBER. THE EIGHT CIRCUITS THAT WERE RETURNED WERE PRESSURED TESTED FOR CHECK FOR LEAKS. THE NINTH DEVICE COULD NOT BE PRESSURE TESTED AS THE CIRCUIT LIMBS WERE NOT RETURNED. RESULTS: A LEAK WAS DETECTED BETWEEN THE SWIVEL ELBOW AND Y-PIECE OF THE BREATHING CIRCUITS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 081118, 100706, 100804, (B)(4) OTHER COMPLAINTS OF THIS NATURE ((B)(4)) FOR LOT NUMBER 100601 AND (B)(4) OTHER COMPLAINT OF THIS NATURE ((B)(4)) FOR LOT NUMBER 100816. CONCLUSION: ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN (B)(4) AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE TWO PARTS THAT MAKE UP THE Y-SWIVEL ARE HELD TOGETHER BY A SNAP-FIT, WHICH HAS SOME INHERENT LEAKAGE THAT IS DETECTED AND COMPENSATED FOR BY THE VENTILATOR. IT IS POSSIBLE THAT IF NOT PROPERLY LOCKED INTO PLACE, THE LEAK BETWEEN THE SWIVEL JOINT WAS ENHANCED DURING TRANSPORT OR SETUP DESPITE HAVING PASSED THE LEAK TEST AT THE TIME OF PRODUCTION. THE RT236 USER INSTRUCTIONS STATE THE FOLLOWING: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE; PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS. OUR MONITORING AND TRENDING OF INFANT BREATHING CIRCUIT SWIVEL LEAKS HAS A RATE OF OCCURRENCE OF (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). LOT NUMBER: 081118, QUANTITY: 1, DATE OF MANUFACTURE: 18 NOVEMBER 2008; 100601, 1, 01 JUNE 2010; 100706, 2, 06 JULY 2010; 100804, 4, 04 AUGUST 2010; 100816, 1, 16 AUGUST 2010; 101004, 1, 04 OCTOBER 2010. METHOD: NINE COMPLETE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION. THE FOLLOWING COMPONENTS OF DEVICE #10 WERE RETURNED: TWO DRY LINES AND ONE MR290 AUTOFEED HUMIDIFICATION CHAMBER. THE NINE BREATHING CIRCUITS THAT WERE RETURNED WERE PRESSURED TESTED FOR CHECK FOR LEAKS. THE 10TH DEVICE COULD NOT BE PRESSURE TESTED AS THE CIRCUIT LIMBS WERE NOT RETURNED. RESULTS: EIGHT BREATHING CIRCUITS THAT WERE PRESSURE TESTED WERE FOUND TO BE LEAKING BETWEEN THE SWIVEL ELBOW AND Y-PIECE CONNECTOR. NO FAULT WAS FOUND WITH THE OTHER BREATHING CIRCUIT DURING PRESSURE TESTING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 081118. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100601. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100706. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100804. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100816. CONCLUSION: ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE TWO PARTS THAT MAKE UP THE Y-SWIVEL ARE HELD TOGETHER BY A SNAP-FIT, WHICH HAS SOME INHERENT LEAKAGE THAT IS DETECTED AND COMPENSATED FOR BY THE VENTILATOR. IT IS POSSIBLE THAT IF NOT PROPERLY LOCKED INTO PLACE, THE LEAK BETWEEN THE SWIVEL JOINT WAS ENHANCED DURING TRANSPORT OR SETUP DESPITE HAVING PASSED THE LEAK TEST AT THE TIME OF PRODUCTION. THE RT236 USER INSTRUCTIONS STATE THE FOLLOWING: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE; PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS. OUR MONITORING AND TRENDING OF INFANT BREATHING CIRCUIT SWIVEL LEAKS HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT TEN RT236 BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. FISHER & PAYKEL HEALTHCARE HAS SINCE BEEN ADVISED THAT THE AFFECTED QUANTITY IS NINE UNITS. THE LEAK TESTS WERE CARRIED OUT PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN THE (B)(6) REPORTED THAT TEN RT236 BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. FISHER & PAYKEL HEALTHCARE HAS SINCE BEEN ADVISED THAT THE AFFECTED QUANTITY IS NINE UNITS. THE LEAK TESTS WERE CARRIED OUT PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN THE (B)(6) REPORTED THAT TEN RT236 BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THE LEAK TESTS WERE CARRIED OUT PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT236 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 MAQUET SERVO-I VENTILATOR| MAQUET SERVO-I VENTILATOR| MAQUET SERVO-I VENTILATOR