BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE PUMP IV SET

    MDR report key: 1564997 · Received November 17, 2009

    Report

    Report Number
    9614279-2009-00031
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    November 23, 2009
    Report Date
    December 14, 2009
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL SAMPLES OF VARIOUS CATALOG NUMBERS WERE RECEIVED FROM THE FACILITY FOR EVALUATION, HOWEVER, NONE OF THE SAMPLES WERE IDENTIFIED AS BEING RELATED TO THE SPECIFIC REPORTED INCIDENT. ALL POSSIBLE SAMPLES WERE TESTED. NO DEFECTS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. AFTER SEVERAL FOLLOW-UP CALLS WITH THE FACILITY TO IDENTIFY THE SAMPLES, THE FACILITY COULD NOT PROVIDE ANY FURTHER INFORMATION TO PROPERLY IDENTIFY IF ANY OF THE SAMPLES RETURNED WERE THE ACTUAL SAMPLES INVOLVED IN THE REPORTED INCIDENT. ALTHOUGH NO INVENTORY REMAINS OF THE REPORTED LOTS, THE HOUSE RETAIN SAMPLES FOR THE REPORTED LOTS WERE ALSO PHYSICALLY TESTED FOR LEAKAGE AND SUBJECTED TO A PULL TEST AT THE BONDED JOINTS. ALL SAMPLES PASSED THE LEAKAGE TEST AND EXCEEDED THE MINIMUM JOINT SEPARATION DESIGN SPECIFICATION, PASSING THE JOINT INTEGRITY TEST. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOTS. NO NON-CONFORMANCES WERE REPORTED DURING THE MANUFACTURE PROCESS. IT IS TO BE NOTED THAT THE FACILITY REPORTED THAT THERE WERE NO AIR BUBBLES NOTED IN THE TUBING THE NIGHT BEFORE WHEN THE TUBING AND THE AIR FILTER WERE CHANGED, OR BEFORE THE PATENT WENT FOR THE ECHOCARDIOGRAM. WITHOUT THE ACTUAL SAMPLES, A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ULTRASITE FILTERED EXTENSION SET. ADDITIONAL DEVICE: FILTERED EXTENSION SET. LOT: 61078616, EXPIRATION DATE: 8/31/2014. ADDITIONAL 510(K): K942988. ADDITIONAL MFR DATE: 09/2009.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: SETS BEING USED ON A FEMALE NICU PATIENT SINCE 5 PM LAST NIGHT. APPROXIMATELY 12 N CENTRAL TIME TODAY, PATIENT WENT FOR AN ECHOCARDIOGRAM AND AN AIR BUBBLE WAS DETECTED IN THE HEART. PATIENT IS DOING OK. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE TUBING AND THE AIR FILTER WERE CHANGED THE NIGHT BEFORE THE INCIDENT OCCURRED. THE NEXT DAY WHEN THE PATIENT WENT FOR AN ECHOCARDIOGRAM, THE DOCTOR SAW AN AIR BUBBLE GO ACROSS THE PATIENT'S HEART. IT WAS ALSO REPORTED BY THE FACILITY THAT THERE WERE NO AIR BUBBLES NOTED IN THE TUBING THE NIGHT WHEN THE TUBING WAS CHANGED OR BEFORE THE PATIENT WENT FOR THE ECHOCARDIOGRAM. THE PATIENT IS FINE AND SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT. IT WAS REPORTED BY THE FACILITY THAT THE SAMPLES WERE GIVEN TO THE SALES REP FOR RETURN. WHEN THE SALES REP WAS CONTACTED, HE REPORTED THE SAMPLES WERE GIVEN BACK TO THE FACILITY. IT WAS THEN REPORTED THAT THE SAMPLES WERE SENT IN BY THE OPERATIONS LEADER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE PUMP IV SET PUMP IV SET FPA B. BRAUN DOMINICAN REPUBLIC NA 61083238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other