BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 18282805 · Received December 7, 2023

    Report

    Report Number
    18282805
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    September 21, 2023
    Report Date
    October 3, 2023
    Manufacturer
    FOOTPRINT MEDICAL, INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REGISTERED NURSE (RN) AND RESPIRATORY THERAPIST (RT) GOT IN WITH BABY TO DO CARES. RN NOTICED THAT THE DRESSING FOR THE UMBILICAL ARTERY CATHETER (UAC) HAD COME LOOSE. THERE WAS A LOT OF TENSION ON THE TUBE AS THE TRANSDUCER HAD FALLEN DOWN IN THE BED. RN RE-SECURED UAC TO ABDOMEN WITH NEW DUODERM AND TEGADERM. UAC SUTURES, VERY THIN AND WHITE, WERE LOOSE AND STRETCHED OUT. ATTEMPT TO REMOVE OLD DRESSING FROM LINE UNSUCCESSFUL, EVEN WITH ADHESIVE REMOVER. BABY WAS NOT TOLERATING TOUCH, BABY DESATURATING. RT ROUTINE SUCTIONED AND A MODERATE FRANK RED BLOOD WAS SUCTIONED. NEONATAL NURSE PRACTITIONER (NNP) NOTIFIED AND AT BEDSIDE. PEEP INCREASED FROM 7 TO 8, BABE ON 100% OXYGEN, NNP SAID TO WAIT TO FINISH CARES FOR BABY TO RECOVER. BABE RECOVERED IN ABOUT 10 MINUTES. NURSE ASKED IF WE COULD DEFER WEIGHT, NNP WANTED A WEIGHT FOR ACCURATE GAIN. BABY WAS VERY EDEMATOUS AND HAD RECEIVED MULTIPLE BLOOD PRODUCTS, DECIDING ON GIVING LASIX. AFTER BABY WEIGHED, NURSE NOTICED THAT THE UAC HAD BROKE AT 25 CM MARK, QUICKLY OCCLUDED. NNP NOTIFIED. BABY PREPARED FOR ANOTHER UAC PLACEMENT. LINE KEPT FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212911 NA CATHETER, UMBILICAL ARTERY FOS FOOTPRINT MEDICAL, INC. P1UVC-2530 221562

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown