BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1040761 · Received May 9, 2008

    Report

    Report Number
    1219856-2008-00223
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 19, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED BY CALL REPORT. CLINICAL ON CALL (COC) RECEIVED A CALL FROM ANSWERING SVC AT 1152 TO PHONE PERFUSIONIST. COC CALLED AT 1158, PERFUSIONIST ANSWERED & HE ASKED IF COC WOULD CALL BACK IN 5 MINUTES. COC PROVIDED HER PHONE NUMBER & ASKED HIM TO CALL BACK WHEN READY. AT 1202 HE CALLED BACK, STATED HE JUST LEFT HOSP, & THEY HAD A SITUATION WHERE HELIUM TANK WAS EMPTYING RAPIDLY (IN 24 HR PERIOD). HE STATED NURSING CHANGED HELIUM TANK BY REMOVING YOLK & EVERYTHING. HE INSTRUCTED THEM TO SCREW TANK ON, BUT WAS CONCERNED THERE WAS ANOTHER PROBLEM. HE STATED PSI SEEMED TO BE LOWERING QUICKLY AGAIN, DOWN TO 487 PSI & THEY JUST CHANGED TANK. THEY DISCUSSED HOW O-RING IS BEHIND HELIUM TANK & MAY BE TOO LOOSE. COC SUGGESTED SOMEONE COULD CHECK O-RING OR IF THEY HAD ANOTHER PUMP THEY COULD CHANGE PUMPS IF THEY DID NOT FEEL COMFORTABLE CHECKING O-RING & HELIUM NEEDED TO BE CHANGED AGAIN. COC SUGGESTED THEIR BIOMED MAY HAVE EXTRA O-RINGS. PERFUSIONIST VERBALIZED CONCERN THAT IF THEY CHANGED PUMP, FOS WOULD NOT WORK. COC EXPLAINED HOW FOS WAS ZEROED TO THAT PUMP, BUT IT COULD BE CALIBRATED TO ANOTHER PUMP IF THEY FELT CHANGING THE PUMP WAS THE BEST OPTION. HE STATED HE DID NOT KNOW THAT & THANKED HER FOR THE INFO. HE ASKED COC TO PHONE NURSE & EXPLAIN SAME OPTION TO HER. COC PHONED NURSE & DISCUSSED HOW TO CHECK PSI UNDER SHOW STATUS. SHE STATED PSI WAS 486, SO IT HAD NOT CHANGED MUCH IN 20 MINUTES. NURSE STATED SHE DID NOT FEEL COMFORTABLE DOING ANYTHING WITH PUMP UNLESS PERFUSIONIST WAS THERE. SHE STATED SHE WOULD PHONE BIOMED & DISCUSS OPTIONS & WATCH PSI ON PUMP. COC PROVIDED HER PHONE NUMBER IF NURSE NEEDED ANY ADD'L INFO OR TO WALK THROUGH CHANGING OF TANK, CHECKING O-RING OR CHANGING OUT PUMP. NO ADD'L CALLS WERE RECEIVED. IN 2008, A FOLLOW UP CALL WAS MADE TO NURSING NUMBER. NURSE STATED THEY HAD PT ON PUMP & EVERYTHING WAS GOOD, CONFIRMED ON SAME PUMP SERIAL NUMBER. HE STATED PSI WAS CURRENTLY 465. HE HAD RECEIVED IN A REPORT THAT THEY HAD A PROBLEM ON SATURDAY, BUT NO OTHER PROBLEMS SINCE THEN. HE STATED THAT HE WAS TOLD TO EXCHANGE HELIUM TANK. COC ASKED IF THEY HAD INSTRUCTION STICKER INSIDE HELIUM TANK DOOR & NURSE STATED THEY DID NOT. HE PROVIDED CONTACT PERSON TO SEND STICKERS TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK