BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFELINT HORIZON PUMP IV SET

    MDR report key: 1051302 · Received May 22, 2008

    Report

    Report Number
    9614279-2008-00026
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 22, 2008
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K904518
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED. THE ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE SET DID NOT MALFUNCTION AND IT IS ONLY A PRESUMPTION THE SET DID NOT FLOW AS QUICKLY AS A STRAIGHT LINE SET. THERE IS NO INDICATION THAT THE RELATED INCIDENT IS DUE TO ANY MANUFACTURING DEFICIENCY OF THE REPORTED SET. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ADD'L LOT #S: 60977193, 60977192. ADD'L EXPIRATION DATE: 01/31/2013.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: PRODUCT USED TO INFUSE SOLUTION TO PATIENT THAT RESULTED IN PT DEATH. OCCURRED WITH A (B) (6) WOMAN, POST PARTUM, HEMORRHAGING, ADMINISTERED IV FLUIDS THROUGH CENTRAL LINE, VIA GRAVITY, AND PRESSURE CUFF ON IV SOLUTION BAG. FACILITY MADE NOTE THAT THE IV FLUIDS "DID NOT SEEM TO FLOW AS QUICKLY VIA THIS SET AS PREVIOUS STRAIGHT LINE BAXTER SETS". ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THAT IT IS ONLY A PRESUMPTION THAT THE IV TUBING USED DID NOT FLOW AS QUICKLY AS A STRAIGHT LINE SET. THE POSITIONING OF THE IV MIGHT HAVE ALSO BEEN A FACTOR. THE SET DID NOT MALFUNCTION AND WAS NOT NECESSARILY RELATED TO THE OUTCOME OF THE INCIDENT. THE SOLUTION RUNNING THROUGH THE SET AT THE TIME OF THE INCIDENT WAS LACTATED RINGERS AND THEN NORMAL SALINE. BLOOD WAS POSSIBLY RUNNING FROM ANOTHER LINE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. THE REPORTED LOT NUMBERS ARE POSSIBLE LOT NUMBERS IN INVENTORY ON THE UNIT AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFELINT HORIZON PUMP IV SET HORIZON PUMP SET FPA B. BRAUN OF DOMINICAN REPUBLIC NA 60982374

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death| O