BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW VPS RHYTHM DLX MONITOR BUNDLE

    MDR report key: 19805846 · Received July 23, 2024

    Report

    Report Number
    9680794-2024-00771
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    May 12, 2024
    Report Date
    July 19, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A VPS RHYTHM DLX MONITOR (SERIAL NUMBER (B)(6)) WITH ACCESSORIES WAS RETURNED. A VISUAL EXAMINATION REVEALED ALL RETURNED ITEMS WERE IN ACCEPTABLE CONDITION WITH NO OBVIOUS EXTERNAL DEFECTS OR ANOMALIES. IT WAS REPORTED "TEAM PLACED DL PICC AT GSH ON 5/12 AND HAD CONFIRMATION OF P WAVE DEFLECTION, CUT AT 39CM WITH 37 INTERNAL AND 2 EX. ON MAY 21ST THE PROVIDERS DID A FOLLOW UP CHEST XR FOR PREVIOUS MEDICAL COMPLAINTS AND THE TEAM NOTICED THE READ STATED, '3CM DEEP INTO THE RIGHT ATRIUM'. THE TEAM PULLED THE LINE BACK 3CM BUT ARE CONCERNED THAT THEY RECEIVED DEFLECTION AND MAX P WAVE BUT THE READING WAS DEEP INTO ATRIUM. THE CLINICIAN DECIDED TO PULL BACK ONLY 2CM AFTER RECEIVING THE RADIOLOGIST READING OF '3CM DEEP INTO THE RIGHT ATRIUM'. A 2ND X-RAY WAS TAKEN, AND THE RADIOLOGIST READ AS '3CM DEEP INTO THE RIGHT ATRIUM'. THE TEAM DECIDED TO LEAVE THE PICC IN THE CURRENT POSITION AS THEY FELT PULLING IT BACK FURTHER WOULD MAKE THE TIP TOO HIGH IN THE SVC". DURING FUNCTIONAL TESTING, MULTIPLE MOCK PROCEDURES WERE PERFORMED. AT NO TIME WERE THERE ANY ISSUES WITH THE FUNCTIONALITY OF THE RETURNED MONITOR. NO PROBLEM WAS FOUND WITH THE RETURNED MONITOR. NO OTHER INFORMATION IS AVAILABLE TO CONFIRM THE REPORTED EVENT. A DEVICE HISTORY RECORD REVIEW PERFORMED ON THE MONITOR DID NOT REVEAL ANY MANUFACTURING OR SERVICING RELATED ISSUES. THE REPORTED ISSUE WAS NOT CONFIRMED DURING EVALUATION OF RETURNED VPS RHYTHM DLX MONITOR. A VISUAL EXAMINATION REVEALED ALL RETURNED ITEMS WERE IN ACCEPTABLE CONDITION WITH NO OBVIOUS EXTERNAL DEFECTS OR ANOMALIES. NO PROBLEM WAS FOUND WITH THE RETURNED MONITOR.TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "TEAM PLACED DL PICC AT GSH ON 5/12 AND HAD CONFIRMATION OF P WAVE DEFLECTION, CUT AT 39CM WITH 37 INTERNAL AND 2 EX. ON MAY 21ST THE PROVIDERS DID A FOLLOW UP CHEST XR FOR PREVIOUS MEDICAL COMPLAINTS AND THE TEAM NOTICED THE READ STATED, 3CM DEEP INTO THE RIGHT ATRIUM. THE TEAM PULLED THE LINE BACK 3CM BUT ARE CONCERNED THAT THEY RECEIVED DEFLECTION AND MAX P WAVE BUT THE READING WAS DEEP INTO ATRIUM." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906394 ARROW VPS RHYTHM DLX MONITOR BUNDLE CATHETER, INTRAVASCULAR, THERAPEUTIC LJS ARROW INTERNATIONAL LLC 151068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED