BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    CATHETER CENTRAL VENOUS 4.2FR 90CM 1 LUMEN 2 CONNECTOR BROVIAC

    MDR report key: 14282262 · Received May 4, 2022

    Report

    Report Number
    14282262
    Event Type
    No answer provided
    Date Received
    May 4, 2022
    Date of Event
    March 20, 2022
    Report Date
    April 28, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LJS
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: RRT (RAPID RESPONSE TEAM) CALLED FOR A PATIENT WITH RESPIRATORY DISTRESS AND DECREASED LVAD (LEFT VENTRICULAR ASSIST DEVICE) FILL/EMPTY. PATIENT EMERGENTLY TRANSFERRED AND CHEST XRAY REVEALED A NEW LARGE PLEURAL EFFUSION. UPON PLACEMENT OF CHEST TUBE TPN AND LIPID APPEARING FLUID "GUSHED" OUT OF THE CHEST TUBE. IT APPEARS HER RA (RIGHT ATRIUM) BROVIAC HAD ERODED OR BEEN DISPLACED. BACKGROUND: PATIENT IS ADOLESCENT WITH CHARGE SYNDROME AND TOF/PA (TETRALOGY OF FALLOT WITH PULMONARY ATRESIA) HAD AN INTRACARDIAC REPAIR WITH LPA (LEFT PULMONARY ARTERY) PATCH AUGMENTATION, RV-PA (RIGHT VENTRICLE ¿ PULMONARY ARTERY) CONDUIT PLACEMENT, ASD (ATRIAL SEPTAL DEFECT) CLOSURE AND PDA (PATENT DUCTUS ARTERIOSUS) LIGATION. POST-OP TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) SHOWED GOOD BIVENTRICULAR FUNCTION, WELL-FUNCTIONING VALVES WITH NO RESIDUAL LESIONS. HER POST-OP COURSE WAS COMPLICATED BY (B)(6) MEDIASTINITIS, EAT, MODERATE MR (MITRAL REGURGITATION) AND WORSENING VENTRICULAR FUNCTION. SHE CONTINUED WITH ARRHYTHMIAS, PROGRESSIVE LV DYSFUNCTION, MODERATE-SEVERE MR, MODERATE TR AND LV NONCOMPACTION/DILATED CARDIOMYOPATHY SO A DECISION WAS MADE TO GO TO THE OR FOR A BERLIN LVAD. IN OPERATING ROOM BERLIN AND BROVIAC WAS PLACED WITH THE TIP OF BROVIAC ENDING IN THE RA. PRIOR TO CHEST TUBE PLACEMENT AND INTUBATION PATIENT WAS GIVEN SEDATION/PARALYTIC IN BROVIAC WITH NO RESPONSE DESPITE MULTIPLE DOSES. WITH THIS NEW FINDING PROVIDER AWARE BROVIAC MAY NOT BE IN THE RIGHT PLACE. EVENT WAS INVESTIGATED FOR POTENTIAL BROVIAC LEAK. UNABLE TO DETERMINE CAUSATION BETWEEN POTENTIAL DEVIATION FROM STANDARDS OF CARE AND ADDITIONAL HARM TO THE PATIENT. OPPORTUNITY IDENTIFIED TO EVALUATE AND CLARIFY STANDARDS OF CARE AROUND ROUTINE ASSESSMENTS OF PATENCY AND POSITION OF INTRACARDIAC LINES. BROVIAC PRODUCT INFO FROM SUPPLY CHAIN USAGE REPORT: VENDOR NAME: BARD PERIPHERAL VASCULAR INC. ITEM DESCRIPTION: CATHETER CENTRAL VENOUS 4.2FR 90CM 1 LUMEN SURECUFF STYLET PEEL APART INJECTION CAP 2 CONNECTOR BROVIAC PEDIATRIC LATEX FREE. ITEM ID: (B)(4). MANUFACTURING ID: (B)(4). MANUFACTURING ITEM ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393905 CATHETER CENTRAL VENOUS 4.2FR 90CM 1 LUMEN 2 CONNECTOR BROVIAC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD PERIPHERAL VASCULAR, INC. 0600524

    Patients

    Seq Age Sex Outcome Treatment
    1 90 DA Female