BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMLINE BLOOD PRESSURE CUFF

    MDR report key: 7074377 · Received December 1, 2017

    Report

    Report Number
    1316463-2017-00010
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 6, 2017
    Manufacturer
    WELCH ALLYN INC.
    Product Code
    DXQ
    PMA / PMN Number
    K080189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN REQUESTED THE RETURN OF THE BLOOD PRESSURE CUFF FOR INVESTIGATION. THE USER FACILITY DECLINED. WITHOUT THE RETURN OF THE BLOOD PRESSURE CUFF AND INFORMATION REGARDING THE MONITOR THAT WAS IN USE WITH THE CUFF AT THE TIME OF THE INJURY, WELCH ALLYN CANNOT COMPLETE FURTHER INVESTIGATION. THE USER FACILITY EVALUATION OF THE BLOOD PRESSURE CUFF SHOWS NO EVIDENCE OF A DEVICE MALFUNCTION. A BLOOD PRESSURE CUFF IS TYPICALLY PLACED OVER THE BRACHIAL ARTERY BECAUSE OF ITS ACCESSIBILITY DURING A SURGICAL PROCEDURE. GOOD STANDARD OF PRACTICE INCLUDES THE REMOVAL OF THE CUFF WHEN THE SITE IS CHANGED OR ROTATED. IF MORE INFORMATION BECOMES AVAILABLE, OR IF THE DEVICE IS RETURNED FOR FURTHER INVESTIGATION, AN UPDATED REPORT WILL BE FILED.

    Description of Event or Problem · 1

    WELCH ALLYN RECEIVED A REPORT STATING A PATIENT RECEIVED A SERIOUS INJURY WHILE A TRIMLINE DISPOSABLE SOFT BLOOD PRESSURE CUFF WAS IN USE DURING A COCHLEAR IMPLANT SURGERY. DURING SURGERY, THE BLOOD PRESSURE MONITORING WAS DISCONTINUED ON THE PATIENT'S RIGHT ARM, AND MONITORING WAS MOVED TO THE PATIENTS LEG. THE CUFF ON THE PATIENT'S RIGHT ARM WAS DISCONNECTED FROM THE MONITOR, BUT WAS LEFT IN PLACE ON THE ARM AND IT IS BELIEVED TO HAVE REMAINED INFLATED, LEADING TO SWELLING AND PARTIAL PARALYSIS OF THE PATIENT'S RIGHT ARM. THE PATIENT COMPLAINS OF NUMBNESS AND TINGLING TO THE LOWER RIGHT ARM BELOW THE ELBOW. THE PATIENT HAD AN ULTRASOUND STUDY OF HER RIGHT ARM AND IT WAS DETERMINED THAT THE PULSE AND BLOOD FLOW TO THE ARM WERE GOOD. THE BLOOD PRESSURE CUFF HAS NOT BEEN RETURNED TO WELCH ALLYN FOR INVESTIGATION. THE RISK REPRESENTATIVE FROM UNIVERSITY (B)(6) STATED THAT TESTING WAS COMPLETED BY THE HOSPITAL BIOMED, AND NO MALFUNCTION COULD BE FOUND WITH THE BLOOD PRESSURE CUFF. THE BIOMED STATED HE BELIEVED THAT THE TUBING WAS KINKED ON THE CUFF. IT IS UNKNOWN WHAT PATIENT MONITOR THE CUFF WAS CONNECTED WITH AT THE TIME OF SURGERY. THIS REPORT WAS FILED IN OUR COMPLAINT SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856624 TRIMLINE BLOOD PRESSURE CUFF TRIMLINE CUFF DXQ WELCH ALLYN INC. CUFF TL DISP,SOFT

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability