BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1124841-2015-00169

    MDR report key: 4788476 · Received May 19, 2015

    Report

    Report Number
    1124841-2015-00169
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 1, 2015
    PMA / PMN Number
    K112229
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS - AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON (B)(6) 2015. A SECOND FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND / OR SUBMISSION OF NEW INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS - AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM. A THIRD FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND / OR SUBMISSION OF NEW INFORMATION, THUS TCVS REFERENCES CONCLUSION CODE 11. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS - AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS. UPON EVALUATION OF THE DEVICE, THE COMPLAINT WAS CONFIRMED. INITIAL VISUAL INSPECTION OF THE ACTUAL SAMPLE REVEALED CRAZING AROUND THE TOP AND BOTTOM HOUSING WELDS. A SMALL CRACK WAS FOUND ON THE TOP HOUSING UNDERNEATH THE OUTLET PORT, AS WELL AS MULTIPLE CRACKS ON THE TOP HOUSING NEAR THE WELD. THE ACTUAL SAMPLE WAS SETUP ON A SARNS DRIVE MOTOR AND BUILT INTO A CIRCUIT OF SALINE SOLUTION. THE RPM WAS SET TO 3500 RPM WITH A BACK PRESSURE OF 660MMHQ. THE SAMPLE BEGAN LEAKING AFTER 10 SECONDS OF TESTING. THE LEAK WAS COMING FROM THE CRACKS IN THE TOP HOUSING LOCATED AT THE TOP HOUSING/SEPARATOR WELD UNDERNEATH THE OUTLET PORT OF THE PUMP. THE CRACK WAS CAUSED BY DEHP COMPOUND RESIDUE ON THE X-COATED SEPARATOR OF THE PUMP. THE SEPARATOR CAME INTO CONTACT WITH DEHP WHEN IT WAS DIPPED INTO THE INCORRECT TANK DURING MANUFACTURE.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CENTRIFUGAL PUMP HEAD LEAKED AND WAS THEN REPLACED. NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA