BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6555696 · Received May 9, 2017

    Report

    Report Number
    9616066-2017-00771
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 21, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 100 ML BAG FRESENIUS KABI NDC 0338-0519-58 LOT 10KI9276 EXP 08/2018 INTRALIPD 20%; UMBILICAL VENOUS DOUBLE LUMEN CATHETER. CONCLUSION CODE FIELD LEFT BLANK - NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE REPORT THAT THE BAG OF INTRALIPIDS WAS FOUND EMPTY PREMATURELY COULD NOT BE CONFIRMED. AT 5:48 PM ON (B)(6) 2017 AN INFUSION OF IVF < 1500 GM WAS PROGRAMMED AT A RATE OF 0.4 ML/HR WITH A VTBI OF 8.8 ML (DURATION OF 22 HOURS). ON (B)(6) 2017 AT 8:38 AM THE MODULE ALARMED FOR AIR IN LINE (AIL). THE INFUSION WAS CONTINUED FOLLOWING THE AIL ALARM AND BETWEEN 8:41 AM AND 10:10 AM THE AIL ALARM RECURRED ALONG WITH FLUID SIDE OCCLUSION ALARMS. DURING THE ALARMS THE USER OPENED THE DOOR AND/OR RESTARTED THE INFUSION. THE VOLUME RECORDED AS INFUSED WAS 6.497 ML. THE CAUSE FOR THE EARLY TERMINATION OF THE INFUSION COULD NOT BE DETERMINED. TESTING AND INSPECTION OF THE PUMP MODULE IDENTIFIED NO MALFUNCTIONS AND THE PUMP MODULE WAS INFUSING WITHIN SPECIFICATIONS. TESTING IDENTIFIED LEAKING FROM A PINHOLE IN THE ADMINISTRATION SET THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT BY INTRODUCING AIR INTO THE SET OR CAUSING THE PREMATURE EMPTYING OF THE BAG. THE CUSTOMER DID NOT REPORT ANY SIGNS OF A LEAK HAVING OCCURRED. THE PROXIMATE CAUSE FOR THE REPORTED EVENT IS BEING ATTRIBUTED TO THE LEAK FROM THE PINHOLE. THE CAUSE OF THE HOLE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CRITICALLY ILL PATIENT WAS RECEIVING AN INTRALIPID INFUSION AT A RATE OF 0.4 ML/HR, AND TPN AT 2.7 ML/HR VIA DIFFERENT LUMENS OF A DOUBLE LUMEN UMBILICAL VEIN CATHETER. THE 100 ML LIPID INFUSION WAS STARTED ON (B)(6) 2017 (AT APPROXIMATELY 5 PM), AND EXPECTED TO INFUSE OVER APPROXIMATELY 22 HOURS. THE BAG WAS DISCOVERED TO BE EMPTY THE FOLLOWING MORNING AT AROUND 8 AM AT THE START OF A CODE RESUSCITATION. THE EVENT IS ESTIMATED TO HAVE OCCURRED BETWEEN 4 TO 8 AM AS PREVIOUS LAB RESULTS RECEIVED AT 4 AM WERE NORMAL. AFTER THE EVENT, THE PATIENT WAS SUCCESSFULLY RESUSCITATED, AND NO SUSTAINED PATIENT EFFECTS OF THE EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335016 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2260-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Required Intervention 8015,(2)8100,8110,PRI TUBING,SPM TUBING,TD (B)(6)