BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4046992 · Received August 26, 2014

    Report

    Report Number
    2249723-2014-00987
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    November 20, 2012
    Report Date
    November 26, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE VERIFIED THE "LOW VACUUM" ALARM ON THE EVENT LOG. THE COMPANY REPRESENTATIVE OBSERVED WHITE CHALKY SUBSTANCE IN VACUUM RESERVOIR, IN ALL LINES FROM THE COMPRESSOR AND UNDER VACUUM HEAD FLAPPER. THE RESERVOIR ASSEMBLY (PART NO. 0202-00-0127), AC LINE CORD CABLE (PART NO. 0012-00-0886-01), P-CLAMP W/ MOUNTING (PART NO. 0343-00-0073), CABLE CLAMP (PART NO. 0343-00-002), SCREW PAN HEADS (PART NOS. 0212-12-0804 AND 0212-12-0806), AND PRESSURE P1 THRU P4 HOSE ASSEMBLY (PART NO. 0004-00-0055) WERE REPLACED. IN AN UNRELATED REPAIR, THE EXPIRED SAFETY DISK (PART NO. 0997-000985-01) WAS REPLACED AND 5000 HOUR PUMP REBUILD KIT (PART NO. 0040-00-0147) WAS INSTALLED AS A PART OF PREVENTIVE MAINTENANCE. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE VACUUM RESERVOIR (PART NO. 0202-00-0127) WAS RETURNED TO (B)(4) REPAIR CENTER, (B)(4) FOR EVAL. THE PRESENCE OF WHITE RESIDUE WAS CONFIRMED. A CAPA WAS INITIATED IN 2009 WITH THE RESERVOIR VENDOR TO ADDRESS A SIMILAR OCCURRENCE FOR THE RESERVOIR WITH (B)(4). THIS CAPA RESULTED IN A VENT HOLE BEING CREATED IN THE RESERVOIRS, AND 100% INSPECTION TO CHECK FOR SALT RESIDUE IN THE RESERVOIR. NOTE: THIS IABP UNIT WAS MANUFACTURED IN 2008, PRIOR TO THIS CAPA. BASED ON THE REVIEW OF THE COMPLAINTS FROM (B)(4) AND THE VAST NUMBER OF IABPS THAT HAVE BEEN DISTRIBUTED WORLDWIDE, THIS EVENT MAY BE CATEGORIZED AS AN ISOLATED EVENT. SINCE THE PART WAS REPLACED AND THE IABP UNIT HAS BEEN FULLY OPERATIONAL AFTER THE REPAIR, NO ADDITIONAL ACTION IS DEEMED NECESSARY. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK OF THE IABP, THE CUSTOMER REPORTED THAT THE IABP GENERATED A "LOW VACUUM" ALARM. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518014 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1