BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL ULTIPOR ANESTHESIA BREATHING SYSTEM

    MDR report key: 3825258 · Received May 21, 2014

    Report

    Report Number
    9680602-2014-00001
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 21, 2014
    Report Date
    June 13, 2014
    Manufacturer
    PALL NEWQUAY
    Product Code
    CAH
    PMA / PMN Number
    K013093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLICATED LOT NUMBER WAS NOT PROVIDED BY THE END USER HOWEVER WE CAN ADVISE THAT SINCE APRIL 2013 FIVE (5) LOT NUMBERS OF VM96DLEX2L (IE. 132023, 132636, 132909, 133235 & 134825) HAVE BEEN SHIPPED TO BEAUMONT HOSPITALS, AS SUCH, A LOT REVIEW WILL BE CONDUCTED ON EACH OF THE POTENTIAL LOT NUMBERS. ADDITIONALLY, ALTHOUGH THE IMPLICATED SAMPLE WAS NOT RETAINED FOR EVALUATION, OUR MANUFACTURING FACILITY IS CONDUCTING AN INVESTIGATION INTO THIS ISSUE AND A FINAL MDR WILL BE SUBMITTED UPON COMPLETION. IT SHOULD ALSO BE NOTED THAT THIS PRODUCT HAS BEEN VALIDATED FOR MULTIPLE PATIENT USE FOR UP TO 24 HOURS WHEN USED IN CONJUNCTION WITH A PALL ULTIPOR ANESTHESIA BREATHING CIRCUIT SYSTEM-PATIENT KIT WITH ULTIPOR 25 FILTER. A FIVE YEAR TREND SEARCH WAS CONDUCTED AND CONFIRMED THAT WE HAVE NO OTHER REPORTS OF THIS NATURE FOR PART NUMBER VM96DLEX2L.

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT RETAINED BY THE CUSTOMER, SO DIRECT EVALUATION WAS NOT POSSIBLE. THE USER DID NOT REPORT THE LOT NUMBER OF THE INVOLVED DEVICE, SO REVIEW OF THE MANUFACTURING HISTORY OF THE MANUFACTURING LOT WAS NOT POSSIBLE. HOWEVER A REVIEW OF THE MANUFACTURING RECORDS FOR THE FIVE LOT NUMBERS SHIPPED TO THE USER FACILITY SINCE APRIL 2013 CONFIRMED THAT THEY WERE ALL MANUFACTURED AND QUALITY CONTROL TESTED IN ACCORDANCE WITH OUR DOCUMENTED PROCEDURES AND MET ALL CRITERIA REQUIRED FOR RELEASE. AS PART OF THE MANUFACTURING INVESTIGATION INTO THE REPORTED TUBING BLOCKAGE THE ASSEMBLY PROCESS OF THE PALL ULTIPOR ANESTHESIA BREATHING SYSTEM, PART NUMBER VM96DLEX2L WAS REVIEWED FOCUSING ON THE MANAGEMENT AND SEGREGATION OF THE ELBOW AND CAP COMPONENTS PRIOR TO AND DURING ASSEMBLY. IN AN EFFORT TO REPRODUCE THE CUSTOMER'S REPORT AN UNSEGREGATED ASSEMBLY AREA WAS PURPOSELY CREATED TO DETERMINE IF THE CAP COULD ENTER THE ELBOW COMPONENT. MANUFACTURING WAS UNSUCCESSFUL IN DUPLICATING THIS OCCURRENCE. (NOTE: THE CAP FOUND IN THE REPORTED ELBOW COMPONENT WAS AN EXTRA CAP FOUND FOLDED INSIDE THE ELBOW). ALTHOUGH IT WAS CONCLUDED THAT THE CAP MOST LIKELY ENTERED THE ELBOW DURING ASSEMBLY A CONCLUSIVE MANUFACTURING ROOT CAUSE COULD NOT BE ESTABLISHED. THE FOLLOWING PREVENTATIVE ACTIONS HAVE BEEN ESTABLISHED TO REDUCE THE POTENTIAL OF A REOCCURRENCE: A QUALITY ALERT WAS ISSUED TO THE MANUFACTURING STAFF. COMPLETED MAY 12, 2014; A RETRAINING OF THE ASSEMBLY PROCESS WAS PROVIDED TO THE OPERATORS. COMPLETED MAY 12, 2014; THE ASSOCIATED PROCESS PROCEDURE WAS REVISED TO INCLUDE FREQUENT CONFIRMATION BY THE LINE LEADER FOR PROPER SEGREGATION OF THE ELBOW AND CAP COMPONENTS. COMPLETED MAY 9, 2014; AN EVALUATION OF THE CAP COLOR WAS CONDUCTED AND WAS CONCLUDED THAT CHANGING THE CAP COLOR TO A DARK BLUE FROM OPAQUE WOULD IMPROVE VISIBILITY AND ENSURE EASY DETECTION. CHANGE CONTROL REQUIREMENTS ARE EXPECTED TO BE COMPLETED BY JUNE 29, 2014. WE BELIEVE THAT THE ABOVE LISTED ACTIONS WILL BE EFFECTIVE IN REDUCING THE POTENTIAL FOR THIS DEVIATION TO OCCUR IN THE FUTURE. WE WILL ALSO PERFORM AN EFFECTIVENESS CHECK SIX (6) MONTHS AFTER IMPLEMENTATION TO ENSURE THE EFFECTIVENESS OF THESE ACTIONS. NO SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS DEVICE MODEL IN THE PAST 5 YEARS. SUMMARY: THE CAUSE OF THE USER'S OBSERVATION IS INDETERMINATE. THE EVENT WAS NOT REPRODUCIBLE. PREVENTATIVE ACTIONS HAVE BEEN TAKEN. CORRECTED DATA: THE INITIAL MDR REPORT SUBMITTED ON 5/21/14, IT WAS INDICATED THAT THE INITIAL REPORTER DID NOT REPORT THIS OCCURRENCE TO THE FDA HOWEVER SUBSEQUENTLY ON 5/27/14 PALL QUALITY ASSURANCE DEPARTMENT RECEIVED A COPY OF THE USER FACILITY MDR, IMPORTER REPORT# (B)(4). UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STAFF WERE EXPERIENCING SOME DIFFICULTY IN VENTILATING A PATIENT WHILE USING A PALL ULTIPOR ANESTHESIA BREATHING CIRCUIT SYSTEM. THE RESPIRATORY TECHNICIAN HAD INSTALLED THE CIRCUIT ON THE PORTS OF THE ANESTHESIA MACHINE, AND CONDUCTED A PRETEST OF THE CIRCUIT. NO FAULTS WERE DETECTED BY THE PRE-TEST, ALTHOUGH THE PRETEST IS TARGETED MORE STRONGLY TOWARD LEAKS. THE CIRCUIT WAS THEN CONNECTED TO THE PATIENT WHO HAD BEEN INTUBATED USING A LARYNGEAL MASK. AFTER STARTING VENTILATION, THE ANESTHESIOLOGIST JUDGED THE FLOW RATED TO BE INSUFFICIENT. EXTERNAL INSPECTION OF THE CIRCUIT DID NOT DISCLOSE ANY OBVIOUS SOURCE OF THE FLOW REDUCTION; THE LARYNGEAL MASK AIRWAY WAS REMOVED FROM THE PATIENT'S AIRWAY AND DETACHED FROM THE BREATHING CIRCUIT. AT THIS TIME, INSPECTION OF THE LUMEN OF THE ELBOW REVEALED A CAP FOLDED ON ITSELF, LODGED IN THE LUMEN OF THE ELBOW. THE USER REMOVED THE CAP, REINTUBATED THE PATIENT WITH A SECOND LARYNGEAL MASK, REATTACHED THE CIRCUIT, AND RESUMED VENTILATION, WITH A SATISFACTORY FLOW ENSUING. THE PROCEDURE WAS CONTINUED WITHOUT ANY FURTHER INCIDENT, AND NO SEQUELAE WERE REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302534 PALL ULTIPOR ANESTHESIA BREATHING SYSTEM PALL ULTIPOR ADULT MACHINE KIT CAH PALL NEWQUAY VM96DLEX2L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention