BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 7890615 · Received September 19, 2018

    Report

    Report Number
    3003263092-2018-00009
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    August 26, 2018
    Report Date
    October 29, 2018
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K072364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION PROVIDED BY THE CUSTOMER REVEALED THAT THE PATIENT SUFFERED FROM A HIT II, A HEPARIN INDUCED THROMBOCYTOPENIA. FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN REQUESTED AND INVESTIGATION IS ONGOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. EXEMPTION NUMBER E2018007 (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVOLVED CATHETER WAS NOT RETURNED AND THE BATCH NUMBER WAS NOT PROVIDED DESPITE SEVERAL REQUESTS. AN INVESTIGATION OF A RETAIN SAMPLE AND A DHR REVIEW OF THE SAME BATCH COULD NOT BE PERFORMED. A REVIEW OF POTENTIAL APPLICABLE DHRS WAS PERFORMED, BUT NO DEVIATIONS RELEVANT TO THE REPORTED ISSUE COULD BE DETECTED. A SIMILAR CATHETER WITH GREATER LENGTH WAS TESTED IN (B)(6) 2016 FOR ITS HEMOCOMPATIBILITY. THE RESULTS SHOW THAT THE REQUIREMENTS FOR THE INTERACTION OF THE TEST ITEM WITH BLOOD ACCORDING TO THE APPLICABLE ISO 10993-4 ARE FULFILLED. THE ISSUE IS MONITORED ON THE MARKET. THE RATE OF COMPLAINTS ABOUT A THROMBOSIS IN ASSOCIATION WITH A PICCO CATHETER KNOWN TO US IS FAR BELOW THE PUBLISHED AVERAGES OF COMPLICATIONS WITH ARTERIAL CATHETERS. ON THE BASIS OF THE OVERALL CIRCUMSTANCES AND THE INVESTIGATIONS OF SIMILAR COMPLAINTS THE INCIDENT IS SEEN AS A KNOWN COMPLICATION OF ARTERIAL CANNULATION. THE INSTRUCTIONS FOR USE (IFU) HAVE SEVERAL INDICATIONS ABOUT THE RISK OF THROMBOSIS. THIS EVALUATION IS SUPPORTED BY INFORMATION PROVIDED BY THE CUSTOMER, WHICH REVEALED THAT THE PATIENT SUFFERED FROM A HIT II, A HEPARIN INDUCED THROMBOCYTOPENIA. PLEASE NOTE, GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF PULSION MEDICAL SYSTEMS SE (EXEMPTION NUMBER E2018007). CONTACT: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OCCLUSION OF THE A. BRACHIALIS AND AN ISCHEMIA IN THE ARM AFTER USING THE PICCO CATHETER FOR 7 DAYS. SURGICAL INTERVENTION WAS NECESSARY. DURING THE TIME OF REQUEST THE PATIENT STATUS WAS STABLE, BUT RESTRICTED DUE TO THE OVERALL SITUATION. (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731328 PULSION PULSIOCATH THERMODILUTION CATHETERS PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention