BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 DOUBLE HEAD PUMP

    MDR report key: 3894246 · Received June 18, 2014

    Report

    Report Number
    1718850-2014-00176
    Event Type
    Other
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE PRODUCT INVOLVED IN THIS ISSUE; FURTHER CLARIFICATION, INCLUDING MODEL AND SERIAL NUMBER WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT WILL FILED ON BEHALF OF SORIN GROUP (B)(4). PATIENT CONDITION NOT PROVIDED. SORIN GROUP RECEIVED A REPORT THAT THE PATIENT DEVELOPED HYPERTENSION SYNDROME AFTER REINFUSION OF AUTOLOGOUS BLOOD PROCESSED BY ATS EQUIPMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PUMP DISPLAYED AN ERROR MESSAGE AND DID NOT ROTATE WHEN THE SPEED CONTROL KNOB WAS TURNED. THE PUMP DID EVENTUALLY ROTATE AFTER SEVERAL ATTEMPTS. THE ISSUE WAS CONFIRMED BY A SERVICE REPRESENTATIVE ON SITE. A LARGE AMOUNT OF GREASE WAS FOUND INSIDE THE KNOB WHICH COULD HAVE CAUSED THE KNOB HOOK TO BREAK. THE CUSTOMER WAS INFORMED, THE KNOB WAS REPLACED AND NO FURTHER ISSUES HAVE BEEN REPORTED. SORIN GROUP (B)(4) STATED THAT NO TREND FOR THIS TYPE OF ISSUE HAS BEEN IDENTIFIED. NO NONCONFORMITIES WERE NOTED DURING MANUFACTURING RECORD REVIEW. THE ISSUE WILL BE MONITORED FOR TRENDS AND IF IDENTIFIED, CORRECTIONS WILL BE RECOMMENDED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT WAS SUBMITTED WITH. SORIN GROUP RECEIVED A REPORT THAT THE PATIENT DEVELOPED HYPOTENSION SYNDROME AFTER REINFUSION OF AUTOLOGOUS BLOOD PROCESSED BY ATS EQUIPMENT. NEW COMMUNICATION CLARIFIED THAT THIS STATEMENT IS USED AS PART OF A DECISION TREE FOR ATS REPORTABLE EVENTS AND WAS INADVERTENTLY MISREAD ON A FORM. THERE WAS NO COMPLAINT REGISTERED REGARDING ATS EQUIPMENT FROM THE CUSTOMER. THE COMPLAINT REGISTERED WITH SORIN GROUP (B)(4) WAS A REPORT THAT A PUMP DISPLAYED AN ERROR MESSAGE AND DID NOT ROTATE WHEN THE SPEED CONTROL KNOB WAS TURNED. THE PUMP DID EVENTUALLY ROTATE AFTER SEVERAL ATTEMPTS. ALTHOUGH THE ISSUE OCCURRED DURING A PROCEDURE, IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. SORIN GROUP (B)(4) MANUFACTURES THE S3 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4).

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE PATIENT DEVELOPED HYPOTENSION SYNDROME AFTER REINFUSION OF AUTOLOGOUS BLOOD PROCESSED BY ATS EQUIPMENT. PATIENT CONDITION NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358134 S3 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-65-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP