BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD - HARDWARE

    MDR report key: 1933539 · Received December 20, 2010

    Report

    Report Number
    6000001-2010-06061
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS NOT SEQUESTERED BECAUSE INTERNAL PAPERWORK WAS DELAYED AND HAS BEEN LOST IN THE FACILITY'S INTEROFFICE MAIL. THE BSR STATED THAT THE FACILITY ATTRIBUTES THE EVENT TO USE ERROR. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AND/OR UPON BAXTER'S INVESTIGATION IS COMPLETE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND SERIAL NUMBER ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE (BSR) CALLED CORPORATE PRODUCT SURVEILLANCE 2-DEC-10 TO RELAY A REPORT RECEIVED 1-DEC-2010 FOR ONE (1) UNKNOWN COLLEAGUE PUMP IN WHICH A PROGRAMMING ERROR WAS DETECTED DURING PATIENT USE ON AN UNKNOWN DATE WITHIN THE PAST TWO WEEKS. A BSR RELAYED THAT A (B)(6) MALE PATIENT, WHO HAD BEEN ADMITTED TO THE HOSPITAL FOR UNKNOWN REASON(S), WAS TO BE ADMINISTERED LEVOPHED. BSR RELAYED THAT A NURSE INTENDED TO PROGRAM THE PUMP FOR 1.5 MCG. THE NURSE LEFT THE ROOM AFTER PROGRAMMING AND STARTING THE PUMP. AFTER AN UNKNOWN PERIOD OF TIME, THE PATIENT COMPLAINED OF CHEST PAIN AND TIGHTNESS OF CHEST. A PHYSICIAN WAS PAGED. THE PHYSICIAN DETECTED THAT THE PUMP WAS ACTUALLY RUNNING 105 MCG. THE PHYSICIAN STOPPED THE PUMP. THE BSR RELAYED THAT "NITRO AND FLUID" WERE GIVEN TO THE PATIENT; WHO WAS STABILIZED, WAS COMFORTABLE, AND RETURNED TO NORMAL BASELINE. THE BSR RELAYED THAT CARDIAC BLOOD TEST(S) WAS/WERE TAKEN AND THAT ALL WAS/WERE NORMAL 20 HOURS POST INCIDENT. THE BSR RELAYED THAT NO INFORMATION IS AVAILABLE ABOUT THE PUMP; THAT IT WAS NOT SEQUESTERED BECAUSE INTERNAL PAPERWORK WAS DELAYED AND HAS BEEN LOST IN THE FACILITY'S INTEROFFICE MAIL. THE BSR STATED THAT THE FACILITY ATTRIBUTES THE EVENT TO USE ERROR. THE BSR ADDED THAT THE FACILITY HAD ORDERED SIGMA PUMPS TO REPLACE ITS COLLEAGUE PUMPS, (B)(6) 2010.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTING CUSTOMER ((B)(6)) INDICATED THAT THE NURSE CARING FOR THE PATIENT ACCIDENTALLY SELECTED THE VOLUME OPTION INSTEAD OF THE DOSE OPTION WHILE PROGRAMMING THE PUMP USING THE (B)(4) FEATURE. THE PUMP THEN CORRECTLY RAN AT THE FASTER RATE WHICH WAS STILL WITHIN THE HIGH DOSE ALERT MARK. PER THE CUSTOMER, THE PUMP ALSO CORRECTLY DID NOT ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE EVENT OR THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - HARDWARE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention LEVOPHED