BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYPUMP C-BLOC RA 400X2-14 W/PCA

    MDR report key: 3042201 · Received April 4, 2013

    Report

    Report Number
    2026095-2013-00054
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    December 21, 2012
    Report Date
    March 20, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K023318
    Removal / Correction Number
    2026095-05-08-2012-001-R
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: CUSTOMER HAS STATED THE PUMP IS NOT AVAILABLE TO RETURN. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. THIS PRODUCT WAS RECALLED AND DISTRIBUTOR WAS NOTIFIED ON 05/21/2012. DISTRIBUTOR ACKNOWLEDGED PRODUCT HAD BEEN QUARANTINED AND THAT THEIR CUSTOMERS HAD BEEN NOTIFIED VIA A FAX BACK NOTIFICATION. DISTRIBUTOR REPORTED DESTRUCTION OF 425 UNITS. THIS IS THE SECOND TIME THIS DISTRIBUTOR HAS REPORTED ONE OF THEIR CUSTOMERS USING RECALL PRODUCT. CONCLUSIONS: I-FLOW HAS NOTIFIED (B)(4)'S SUPPLY CHAIN MANAGEMENT OF THIS OCCURRENCE ON (B)(4) 2013. AS OF THIS DATE ((B)(4) 2013) I-FLOW HAS NOT RECEIVED A RESPONSE.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 400ML. FLOW RATE: 2ML. PROCEDURE: KASAI INTERVENTION OF BILARY ATRESIA. CATHPLACE: CATHETER AUXILLIARY NERVOUS PERIPHERY. REPORTER STATED PUMP WAS DAMAGED. LEAK OR FLOW INCREASED AS VACUUM BOTTLE FOUND IN PT'S BED. PUMP WAS PLACED ON PT (B)(6) 2012 AND INFUSION BEGAN 1630. PUMP FOUND EMPTY IN BED OF PT AND INFUSION STOPPED AT 0130 ON (B)(6) 2012. PT EXPERIENCED CONVULSIVE FIT, UNCOMFORTABLE SENSATION AND CARDIAC-RESPIRATORY ARREST. PT STATUS AS OF (B)(6) /2012, TRANSFERRED TO GASTRO-ENTEROLOGY AFTER FAVORABLE COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138826 EASYPUMP C-BLOC RA 400X2-14 W/PCA ELASTOMERIC PUMP MEB I-FLOW, LLC 444008 192472

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Life Threatening| R CALCIUM GLUCONA| GARDENAL| ADRENALINE| SODIUM BICARBONATE