BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERPICC

    MDR report key: 2632568 · Received June 27, 2012

    Report

    Report Number
    2632568
    Event Type
    Death
    Date Received
    June 27, 2012
    Date of Event
    February 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT HAD A HISTORY OF RETROPERITONEAL LIPOSARCOMA. THE PATIENT HAD MULTIPLE RESECTIONS WITH RECENT HEMICOLECTOMY AND SOFT TUMOR RESECTION FOR REOCCURRENCE ADMITTED EARLIER THIS YEAR WITH WORSENING FATIGUE, HYPOTENSION & FEVER. THE PATIENT HAD EMERGENT SURGICAL INTERVENTION FOR BOWEL LEAK AND INTRA-ABDOMINAL FLUID COLLECTION. THE PATIENT WAS TREATED WITH VANCOMYCIN AND MEROPENEM, STARTED ON TPN, AND A WIRE GUIDED ARTERIAL LINE WAS PLACED IN THE RIGHT RADIAL. A RIGHT IJ TRIPLE LUMEN COOK MIN/RIF WAS PLACED. SIX DAYS LATER BARD POWERPICC 5F 32 CM. LOT # REWA0409 WAS PLACED. THE NEXT DAY THE PATIENT LOST CONSCIOUSNESS WHEN HE GOT OUT OF BED TO USE THE BATHROOM. THE PATIENT WAS FOUND TO BE HYPOTENSIVE, TACHYCARDIC, AND OXYGEN SATURATION WAS 88%. HE WAS INTUBATED, AND HAD PROGRESSIVE HYPOTENSION THAT WAS UNRESPONSIVE TO LEVOPHED AND VASOPRESSIN. HE BECAME BRADYCARDIC AND UNRESPONSIVE TO ATROPINE. HE PROGRESSED TO PEA ARREST. DURING THE RESUSCITATION ATTEMPT THE FOLLOWING DRUGS WERE GIVEN: EPINEPHRINE, VASOPRESSIN, AMIODIRONE, CA, SODIUM BICARB, IV FLUIDS. AN ADDITIONAL CENTRAL VENOUS CATHETER WAS PLACED IN THE LEFT IJ DURING THE RESUSCITATION. THE PATIENT WAS DEFIBRILLATED FOR V-FIB. AUTOPSY SHOWED UNEXPECTED FINDING: PRESENCE OF FOREIGN MATERIAL EMBOLI IN THE SMALL AND MEDIUM SIZED PULMONARY ARTERIES. PER THE PATHOLOGIST "MUCH OF THE MATERIAL HAD THE HISTOLOGICAL APPEARANCE OF HYDROPHILIC GEL WHICH COATS CATHETERS USED FOR LINE PLACEMENT. THE CAUSE OF DEATH IS ATTRIBUTED TO MULTIPLE SCATTERED EMBOLI WITHIN THE DISTAL PULMONARY ARTERIES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERPICC CATHETER, PICC LJS BARD ACCESS SYSTEMS UNK REWA0409
    2 TRIPLE LUMEN COOK MIN/RIF CATHETER, CENTRAL VENOUS FOZ COOK MEDICAL UNK UNK
    3 UNK ARTERIAL LINE DTM UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death