BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW VPS RHYTHM ECG ONLY PACK WITHOUT JOHANS

    MDR report key: 9818503 · Received March 11, 2020

    Report

    Report Number
    9680794-2020-00139
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    December 16, 2019
    Report Date
    February 28, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORT "CATHETER TIP LOCATION INCORRECT" WAS NOT CONFIRMED SINCE THE SAMPLE WAS NOT RETURNED FOR REVIEW. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. HOWEVER, THIS COMPLAINT IS ONE OF EIGHTEEN ASSOCIATED COMPLAINTS FILED AT THE SAME TIME FOR "IT IS UNKNOWN WHY THE TRACE SHOWED AN INCREASE ON THE P-WAVE WHEN IT WAS NOT IN THE LOWER 1/3 OF THE SVC", OR IN OTHER WORDS "CLINICIANS REPORTED THAT CATHETER TIP PLACEMENT WHEN USING THE VPS RHYTHM DEVICE DOES NOT CORRELATE TO CONFIRMATORY CHEST X-RAYS". EACH OF THE COMPLAINTS WAS ACCOMPANIED BY A PHOTO OF THE TIP CONFIRMATION CHECKLIST FOR THE PROCEDURE BEING PERFORMED. A MATERIAL SAMPLE WAS NOT RETURNED FOR ANY OF THE COMPLAINTS. NO COPIES OF THE CHEST X-RAYS WERE PROVIDED FOR REVIEW. THE SR. GLOBAL STRATEGIC CLINICAL MARKETING MANAGER REVIEWED ALL EIGHTEEN COMPLAINTS. THE SR. GLOBAL STRATEGIC CLINICAL MARKETING MANAGER CONCLUDED, BASED ON THE OBSERVATIONS OF THE TIP CONFIRMATION CHECKLISTS, IT IS POSSIBLE THAT WHEN USING CONFIRMATORY CHEST X-RAYS, APPROPRIATE TECHNIQUES WERE NOT FOLLOWED TO REMOVE CXR VARIABLES. THESE VARIABLES INCLUDE KEEPING THE PATIENT IN THE SAME POSITION AS WHEN THE CATHETER WAS PLACED, KEEPING THE HEAD OF THE BED IN THE SAME POSITION AS WHEN THE CATHETER WAS PLACED, HAVING THE CHEST X-RAY TUBE AT A 90 DEGREE ANGLE TOWARDS THE PATIENT AND THE PATIENT FLAT, AND HAVING RADIOLOGY READ EACH CONFIRMATORY CHEST X-RAY IN THE SAME MANNER. THESE VARIABLES ARE WELL DOCUMENTED IN PUBLISHED CLINICAL STUDIES. IT IS RECOMMENDED THAT CLINICAL EDUCATION BE PROVIDED TO THE CLINICIANS MANAGING THE ACCOUNT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE SR. GLOBAL STRATEGIC CLINICAL MARKETING MANAGER, THE PROBABLE ROOT CAUSE IS USER ERROR -UNINTENTIONAL - CLINICIAN TECHNIQUE. BASED ON THE RECOMMENDATION OF THE SR. GLOBAL STRATEGIC CLINICAL MARKETING MANAGER, AN IN SERVICE IS BEING REQUESTED TO REVIEW APPROPRIATE TECHNIQUES TO REMOVE CXR VARIABLES.

    Description of Event or Problem · 0

    THE INSERTER MEASURED 45CM AND USED THE VPS WITH ECG CABLE TO DETERMINE THE OPTIMAL PLACEMENT. WHEN INSERTED TO 45CM THE TRACE LOOKED OPTIMAL , AND THE INSERTER WAS HAPPY TO LEAVE THE TIP THERE. THE CXR SHOWED THAT THE LINE WAS IN THE ATRIUM AND THE LINE HAD TO BE PULLED BACK BY 2CM.

    Additional Manufacturer Narrative · 1

    (B)(4). POTENTIAL LOT NUMBER: 13F19D0025, 13F18A0389, 13F19D0025, 13F19D0025, 13F19J0416.

    Description of Event or Problem · 1

    THE INSERTER MEASURED 45CM AND USED THE VPS WITH ECG CABLE TO DETERMINE THE OPTIMAL PLACEMENT. WHEN INSERTED TO 45CM THE TRACE LOOKED OPTIMAL , AND THE INSERTER WAS HAPPY TO LEAVE THE TIP THERE. THE CXR SHOWED THAT THE LINE WAS IN THE ATRIUM AND THE LINE HAD TO BE PULLED BACK BY 2CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283415 ARROW VPS RHYTHM ECG ONLY PACK WITHOUT JOHANS CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1