BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMLINE DISPOSABLE BLOOD PRESSURE CUFF

    MDR report key: 3077692 · Received April 12, 2013

    Report

    Report Number
    1316463-2013-00007
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 22, 2013
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DXQ
    PMA / PMN Number
    K080189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BP CUFF HAS BEEN DISCARDED, AND WILL NOT BE RETURNED TO WELCH ALLYN FOR EVAL. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS CONNECTED TO AN UNKNOWN MODEL DRAEGER DEVICE THAT PERFORMED THE BP MEASUREMENTS DURING SURGERY. SINCE THE CUFF WAS DISCARDED, THE ACTUAL SIZE OF THE CUFF USED IS UNK. THE COMPLAINANT STATED THAT THEY REPORTED THE MATERIAL NUMBER TO IDENTIFY THE TYPE OF CUFF BUT THEY HAVE NO RECORD OF THE SIZE USED. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO GATHER ADD'L INFO ON THIS EVENT. WELCH ALLYN DOES NOT BELIEVE THAT THE TRIMLINE BP CUFF MALFUNCTIONED OR CAUSED OR CONTRIBUTED TO THE ALLEGED INJURY. THE BP MONITOR IS RESPONSIBLE FOR THE INFLATION OF THE CUFF AND OCCLUSION OF THE BLOOD FLOW. THE BP CUFF ITSELF IS A PASSIVE DEVICE. WE ARE FILING THIS REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INJURY WAS SUSTAINED FOLLOWING A PROCEDURE FOR WHICH BLOOD PRESSURES WERE TAKEN EVERY 5 MINUTES WITH A TRIMLINE BLOOD PRESSURE CUFF ON AN UNSPECIFIED DRAEGER MONITOR. THE CUSTOMER STATED THE PATIENT WAS A (B)(6) HEALTHY MALE, HEIGHT WEIGHT PROPORTIONATE, WHO WHEN AWAKING IN RECOVERY COMPLAINED OF ARM PAIN (LEFT) AND HAD REDNESS AND SWELLING. THE PATIENT THEN DEVELOPED ACUTE RENAL FAILURE. AT THE TIME OF THE COMPLAINT, THE CUSTOMER STATED THAT THE PATIENT'S ACUTE KIDNEY FAILURE HAS RESOLVED AND AT LAST KNOWN FOLLOW UP APPROX ONE MONTH AGO THE PATIENT HAD MINOR NUMBNESS AND TINGLING TO THE ARM BUT WAS EXPECTED TO FULLY RECOVER. WELCH ALLYN RECEIVED A MEDWATCH REPORT (B)(4) FOR THIS EVENT ON (B)(6) 2013. THE CUSTOMER DID NOT PROVIDE A PATIENT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159518 TRIMLINE DISPOSABLE BLOOD PRESSURE CUFF DXQ WELCH ALLYN, INC. CUFF TL DISP, SOFT, A UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention