BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE GERMAN

    MDR report key: 2992957 · Received March 1, 2013

    Report

    Report Number
    1219856-2013-00051
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 9, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INFORMATION RECEIVED ON 28FEB 2013 STATED THAT THE MD DECIDED NOT TO SWITCH TO ANOTHER PUMP, ALTHOUGH ONE WAS AVAILABLE. IAB THERAPY WAS NO LONGER NECESSARY, THEY USED THE IAB AS A TRANSDUCER. AN UPDATE ON 05MAR2013 STATED THAT IT WAS CONFIRMED THAT THEY LEFT THE IAB IN THE PATIENT FOR ARTERIAL PRESSURE. DEVICE EVALUATION: NO PARTS OR RECORDER STRIPS WERE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED FROM TELEFLEX GERMANY. A LOCAL SERVICE PROVIDER CHECKED THE PUMP. THE PNEUMATIC CONTROL SWITCH (PCS) ASSEMBLY VALVE BLOCK AND VALVE CONTROL PLUG CONTACT WERE CLEANED. THE PUMP WAS TESTED AND PASSED ALL FUNCTIONAL TESTING. THE ISSUE WAS RESOLVED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF "DURING USE THE PUMP ALARMED "VENT ERROR 5" PURGE FAILURE IS CONFIRMED BY THE LOCAL SERVICE PROVIDER. THE CAUSE OF THE COMPONENT FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE INTENSIVE CARE UNIT DURING USE. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE TEFLON SHEATH VIA LEFT FEMORAL WITH NO ISSUES. DURING USE, THE PUMP (S/N (B)(6) ALARMED "VENT ERROR 5 ". THE HELIUM TANK WAS FILLED, TIMING SETTINGS WERE CORRECT AND NO LEAK IN THE IAB LINE OR CONNECTIONS WERE OBSERVED AFTER RESETTING THE PUMP, THE ALARM REOCCURRED IMMEDIATELY. AS A RESULT, THE PUMP WAS NOT USED AND THIRD-PARTY SERVICE PROVIDER SUPPORT WAS REQUESTED. THERE WERE NO PUMP STRIPS GENERATED. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME WAS OKAY. ADDITIONAL INFORMATION RECEIVED ON 12FEB2013 STATED THAT THE THIRD-PARTY SERVICE PROVIDER CONFIRMED THAT THE PUMP SHOWED THE ERROR "VENT ERROR 5 /ENTLUFTUNGSFEHLER 5 ". AS A RESULT, THE PUMP WAS REMOVED AND THE IAB WAS USED TO APPLY DRUGS. IT IS STATED THAT IT IS UNKNOWN HOW LONG THE DELAY OR INTERRUPTION IN THERAPY WAS. FURTHER ADDITIONAL INFORMATION RECEIVED ON 19FEB2013 FROM THE SALES REPRESENTATIVE STATED THAT THE IAB WAS NOT REMOVED BUT USED AS A TRANSDUCER. AN UPDATE RECEIVED ON 25FEB2013 REPORTED THAT THERE WAS NO IAB THERAPY PERFORMED. THE ALARM OCCURRED IMMEDIATELY AFTER CONNECTING TO THE PUMP, THEREFORE THE IAB WAS USED AS A TRANSDUCER THE PUMP WAS NOT SWITCHED OUT.

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER ADD'L INFO RECEIVED ON (B)(6) 2013 FROM THE SALES REP STATED THAT THE IAB WAS NOT REMOVED, BUT USED AS A TRANSDUCER. AN UPDATE RECEIVED ON (B)(6) 2013 REPORTED THAT THERE WAS NO IAB THERAPY PERFORMED. THE ALARM OCCURRED IMMEDIATELY AFTER CONNECTING TO THE PUMP, THEREFORE, THE IAB WAS USED AS A TRANSDUCER. THE PUMP WAS NOT SWITCHED OUT. DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE INTENSIVE CARE UNIT DURING USE. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE TEFLON SHEATH VIA LEFT FEMORAL WITH NO ISSUES. DURING USE, THE PUMP (SN (B)(4)) ALARMED "VENT ERROR 5." THE HELIUM TANK WAS FILLED, TIMING SETTINGS WERE CORRECT AND NO LEAK IN THE IAB LINE OR CONNECTIONS WERE OBSERVED. AFTER RESETTING THE PUMP, THE ALARM REOCCURRED IMMEDIATELY. AS A RESULT, THE PUMP WAS NOT USED AND THIRD PARTY SERVICE PROVIDER SUPPORT WAS REQUESTED. THERE WERE NO PUMP STRIPS GENERATED. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PT OUTCOME WAS OKAY. ADD'L INFO RECEIVED ON (B)(6) 2013 STATED THAT THE THIRD PARTY SERVICE PROVIDER CONFIRMED THAT THE PUMP SHOWED THE ERROR "VENT ERROR 5/ENTLUFTUNGSFEHLER 5." AS A RESULT, THE PUMP WAS REMOVED AND THE IAB WAS USED TO APPLY DRUGS. IT IS STATED THAT IT IS UNK HOW LONG THE DELAY OR INTERRUPTION IN THERAPY WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272211 AUTOCAT 2 WAVE GERMAN INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC. KC6075347

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown INTRA-AORTIC BALLOON