BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT OPEN HEART PACK W/HMO 71000

    MDR report key: 4093116 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00361
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED KIT WAS HOOKED UP TO AN AIR PRESSURE LINE AND IT AS VERIFIED THAT ONE OF THE SOFT Y-FITTINGS IN THE KIT LEAKED. THE LEAK OCCURRED ON THE OVERLAP JOINT, BETWEEN THE PVC TUBE AND THE Y-FITTING ON THE INSIDE OF THE JOINT. SUBSEQUENT TO THE LEAK INVESTIGATION, THE LEAKING Y-FITTING FROM (B)(4) WAS SECTIONED AWAY FROM THE REST OF THE KIT, DISSECTED AND REVIEWED UNDER MICROSCOPE. UPON REVIEW, A CHANNEL WHERE NO SOLVENT IS PRESENT IS PRESENT WAS VISUALLY OBSERVED ON BOTH THE TUBE AND THE PVC TUBE IN THE AREA WHERE THE LEAK OCCURRED. IN ORDER TO VERIFY THIS IS NOT A TRAIT THAT OCCURS ON ALL OF THE OVERLAP JOINTS, A SECOND Y-FITTING FROM THE SAME KIT, WHICH DID NOT LEAK WAS DISSECTED AND REVIEWED UNDER MICROSCOPE AND THERE WERE NO CHANNELS OBSERVED. THIS IS EVIDENCE THAT THE LEAKING OF THE JOINT WAS DUE TO A CHANNEL BETWEEN THE Y-FITTING AND THE PVC TUBE. THE NEXT STEP WAS TO DETERMINE WHAT CAUSE THE CHANNEL AND TO DETERMINE WHY THE LEAKS WEREN'T DETECTED SINCE ALL SUBASSEMBLIES ARE PUT THROUGH A 100% IN PROCESS LEAK INSPECTION AFTER BONDING AT A PRESSURE BETWEEN (B)(4) PSI FOR (B)(4). A POTENTIAL REASON FOR THE CHANNEL TO OCCUR IS THAT THE SAMPLES WERE LEAK TESTED TOO SOON AFTER BONDING AND THE AIR PRESSURE CAUSED THE CHANNEL IN THE PARTS THAT WERE NOT ALLOWED TO CURE LONG ENOUGH. AN ALTERNATE REASON IS THAT THE SOLVENT WAS SCRAPED OFF DURING THE INSERTION OF THE TUBES INTO THE Y-FITTING. REGARDLESS OF THE CAUSE FOR FAILURE, THE LEAKING Y-FITTINGS WERE NOT DETECTED DURING 100% LEAK INSPECTION. THIS MAY BE DUE TO THE FACT THAT THE LEAK TEST IS (B)(4) SECONDS LONG, (B)(4) OF THOSE SECONDS ARE USED TO FILL THE SUBASSEMBLY AND THE REMAINING (B)(4) SECONDS ARE TESTING THE SAMPLE. THAT TOTAL TEST TIME MAY NOT HAVE BEEN ENOUGH TO VERIFY THE LEAKING SAMPLE. DURING THE INVESTIGATION, IT WAS LEARNED FROM THE (B)(6) SITE THAT THE LEAKING Y-FITTING HAS ALSO OCCURRED THERE AND, IN ORDER TO RESOLVE THE ISSUE, THE PVC TUBE IS STRETCHED PRIOR TO SOLVENT BONDING IT INTO THE Y-FITTING TO PROVIDE A TIGHTER FIT BETWEEN THE TWO COMPONENTS AND THAT ADDITIONAL MANUFACTURING STEP HAS RESOLVED THE ISSUE. IMMEDIATELY UPON LEARNING OF THIS, A DEVIATION TO THE PROCESS ((B)(4)) WAS INITIATED TO IMPLEMENT 100% INSPECTION OF THE PVC TUBE OD AND A TUBE STRETCHING PROCEDURE PRIOR TO SOLVENT BONDING THESE TWO (2) COMPONENTS. IN ADDITION TO THE PHYSICAL REVIEW OF THE FAILED PRODUCT, THE PRODUCT SPECIFICATIONS FOR BOTH THE ADAPTER CONNECTOR AND THE PVC TUBE WERE REVIEWED TO DETERMINE IF THERE WERE ANY TOLERANCE ISSUES THAT COULD LEAD TO A LEAKING JOINT. IN THIS CASE, THE JOINT IS A SOLVENT BONDED JOINT AND WOULD REQUIRE A SMALL INTERFERENCE FIT IN ORDER TO PROVIDE A SECURE, LEAK FREE JOINT. THE SPECIFICATIONS FOR THE COMPONENTS INDICATE THAT THE ID OF THE ADAPTER CONNECTOR AND THE OD OF THE TUBING; AT WORST CASE, WILL BE A LINE TO LINE FIT AT THE OUTER EDGE OF THE ADAPTER CONNECTOR AND THERE WILL BE AN INTERFERENCE FIT THROUGHOUT THE INSIDE OF THE CONNECTOR. IN CONCLUSION, THE ROOT CAUSE OF THE LEAKING PARTS CAN BE ATTRIBUTED TO THE CHANNEL BETWEEN THE PVC TUBE AND THE Y-FITTING. THE TUBE STRETCHING HAS BEEN IMPLEMENTED TO MIMIC THE PREVENTATIVE ACTIONS PERFORMED AT THE (B)(6) SITES TO ADDRESS THE SAME ISSUE. AN ADDITIONAL 100% TUBE OD INSPECTION HAS ALSO BEEN ADDED TO PROVIDE FURTHER CONFIDENCE THAT A PROPERLY SIZED TUBE IS BEING BONDED TO THE Y-FITTING. BASED UPON THE FINDINGS OF THIS INVESTIGATION, AFTER THE Y-FITTINGS HAVE BEEN SOLVENT BONDED, A (B)(4) WAIT WILL BE INSTITUTED PRIOR TO LEAK TESTING AND THE LEAK TESTING TIME WILL BE INCREASED TO A TOTAL OF (B)(4). IT IS BELIEVED THAT A COMBINATION OF THE STRETCHING INSPECTION, SPECIFIED CURE TIME AND LONGER TEST TIME SHOULD RESOLVE THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    LEAKING FROM THE SOFT "WYE" ON THE 4:1 BRIDGE OF THE CARDIOPLEGIA PACK LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506760 ADULT OPEN HEART PACK W/HMO 71000 CARDIOPULMONARY DEVICE DTZ DATASCOPE CORP BEQ-TOP 4903 12973

    Patients

    Seq Age Sex Outcome Treatment
    1