BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITRGLYRN MACRO MICR

    MDR report key: 1802462 · Received August 6, 2010

    Report

    Report Number
    9613251-2010-00097
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 8, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K821515
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4). ADD'L INFO FROM THE USER FACILITY REPORT: (B)(6)2010. REPORT DATE: 07/12/2010. BRAND NAME: NITROGLYCERIN PRIMARY I.V. PUMP SET/ LATEX-PREC. COMMON DEVICE NAME: NITROGLYCERIN PRIMARY I.V. PUMP SET. MFR NAME AND ADDRESS: HOSPIRA INC. (B)(4). CATALOG#: 11993-78. DEVICE AVAILABLE FOR EVALUATION: YES. 07/14/2010.(B)(6)

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH REC'D THAT STATED: "IT WAS REPORTED BY THE ICS NURSING UNIT THAT THE LARGE VOLUME PUMPS USED IN THAT UNIT WERE UNDER INFUSING MEDICATIONS. AFTER EXTENSIVE TESTING BY THE CLINICAL ENGINEERING DEPARTMENT, IT WAS DISCOVERED THAT PROBLEMATIC DELIVERY WAS WITH THE DEHP FREE NITROGLYCERIN I.V. TUBING SETS FROM LOT# 82 167 4W AND WILL UNDER-INFUSE 5% TO 15%. THE LARGE VOLUME PUMPS WERE CHECKED USING NORMAL IV TUBING SET AS WELL AS THE NITROGLYCERIN PRIMARY I.V. PUMP SET FROM A DIFFERENT LOT NUMBER AND THE PUMPS PERFORMED AS EXPECTED AND WITHIN MFR SPECIFICATION. THE HOSPITAL HAS PULLED THE PROBLEMATIC I.V. PUMP SET WITH THE EFFECTED LOT NUMBER AND REPLACED IT WITH THE SAME PRODUCT NUMBER, ONLY WITH A DIFFERENT LOT NUMBER. AFTER EXTENSIVE TESTING BY CLINICAL ENGINEERING IT WAS DISCOVERED THAT THE PROBLEM OF UNDER DELIVERY WAS WITH THE DEHP FREE NITROGLYCERIN PRIMARY I.V. PUMPS SET, FROM LOT# 82 167 4W AND WILL UNDER INFUSE 5% TO 15%. SALES REP WAS NOTIFIED BY PHONE, WILL PICK UP 5 CASES OF EFFECTED PRODUCT WITH LOT NUMBER 82 167 4W, TO BE RETURNED TO MFR FOR EVAL OF PROBLEMATIC PRODUCT." UPON FURTHER QUERY THE FOLLOWING INFO WAS PROVIDED THAT INDICATED, A GENERAL REPORT OF THE PTS RECEIVING LESS MEDICATION THAN INTENDED. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED VOLUMES OF VP16 CHEMOTHERAPY AT A RATE OF 400ML/HR VIA SIGMA INFUSION PUMPS. NO FURTHER PUMP PARAMETERS WERE PROVIDED. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE NURSE EXPECTED THE DELIVERIES TO BE COMPLETED, BUT NOTED THAT SOLUTION REMAINED IN THE SOLUTION CONTAINERS. IT WAS REPORTED THAT THE DELIVERIES WERE COMPLETED USING THE SAME TUBING SETS. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THE STAFF WAS REEDUCATED ON PROPER TUBING LOADING TECHNIQUES. AFTER A SECOND OR THIRD SUBSEQUENT EVENT CLINICAL ENGINEERING WAS NOTIFIED. DURING TESTING OF REP DEVICES AT THE USER FACILITY, IT WAS NOTED THAT DEVICES DELIVERED WAS LESS THAN EXPECTED. THE CUSTOMER CONTACT STATED THAT DELIVERY ACCURACY TESTS WERE PERFORMED USING PUMPS THAT HAD BEEN IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITRGLYRN MACRO MICR 80FPA FPA HOSPIRA LTD. NA 821674W

    Patients

    Seq Age Sex Outcome Treatment
    1 SIGMA SPECTRUM LARGE VOLUME INFUSION PUMPS