BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT SPACE PUMP SETS WITH ULTRASITE

    MDR report key: 3745774 · Received March 19, 2014

    Report

    Report Number
    9614279-2014-00006
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 19, 2014
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). DURING F/U CORRESPONDENCE WITH THE REPORTING FACILITY, IT WAS CLARIFIED THAT THERE WAS ONLY ONE TUBING SET INVOLVED IN THE REPORTED INCIDENT. THE CUSTOMER'S INITIAL STATEMENT THAT THIS "OCCURRED ON THE SAME UNIT 7-8 TIMES IN THE LAST 6 WEEKS" REFERS TO SEVEN MAINTENANCE WORK ORDER REQUESTS FOR SEVEN DIFFERENT PUMPS THAT WERE REC'D BY THE FACILITIES BIOMED DEPARTMENT. ONE USED SPACE PUMP IV SET, WITHOUT THE ORIGINAL PACKAGING, WAS REC'D FOR EVALUATION. THE SET WAS SUBJECTED TO AN AIR PRESSURE (LEAKAGE) TEST ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. THE SET WAS THEN RE-TESTED, WITH THE ADD'L CONDITION OF CLOSING THE ROLLER CLAMP DURING TESTING. DURING THIS TEST, THE ROLLER CLAMP FUNCTIONED PROPERLY AND NO LEAKAGE WAS OBSERVED. THE TUBING SET WAS THEN LOADED INTO AN INFUSOMAT SPACE PUMP (ID # 8267) IN ACCORDANCE WITH THE PUMP INSTRUCTIONS FOR USE (IFU). THE SET WAS TESTED SUCCESSFULLY IN THE PUMP WITHOUT THE PUMP ALARMING ANY ERRORS. THE REPORTED INCIDENT WAS UNABLE TO BE DUPLICATED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. ALTHOUGH NO SPECIFIC CONCLUSION CAN BE DRAWN, THE REPORTED EVENT OF 'FREE FLOW FROM THE PUMP' WAS ONLY ABLE TO BE REPLICATED WHEN MISLOADING THE SET INTO THE PUMP. PER THE PUMP'S IFU, THE SILICONE TUBING SEGMENT SHOULD NOT BE TWISTED DURING SET LOADING; AND THE GREEN FLOW CLIP IS TO BE INSERTED UNTIL THE OPENING LEVER LOCKS IN, THE SAFETY CLAMPS SQUEEZES THE LINES, AND THE FLASHING SIGNAL LAMP GOES OUT. WHILE THE REPORTED EVENT WAS FILED BY THE CUSTOMER AS A POTENTIAL ISSUE WITH THE TUBING SET, THIS REPORT IS BEING FURTHER INVESTIGATED IN CONJUNCTION WITH THE INVOLVED PUMP (IDENTIFIED AS MFG REPORT # 9610825-2014-00033 / (B)(4) / B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4)). REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED TUBING SET LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS NURSING COMPLAINED OF FREE FLOW FROM THE PUMP WHEN ADMINISTERING FLUIDS/MEDICATION TO THE PATIENT. CUSTOMER INDICATED THERE WAS A PATIENT INJURY, BUT DID NOT KNOW SPECIFICS. CUSTOMER VERBALIZED THAT THIS HAS OCCURRED ON THE SAME UNIT 7-8 TIMES IN THE LAST 6 WEEKS. CUSTOMER WITNESSED THE FREE FLOW FROM THE PUMP WHEN USING THE SAME TUBING THAT WAS USED WITH THE PATIENT WHEN ATTEMPTING TO RECREATED IT WITH THE NURSE EDUCATOR. THE PUMP READ "POSSIBLE FREE FLOW SET CLAMP". THE CUSTOMER STATED, "IT MAY BE THE TUBING THAT IS CAUSING IT, A BAD LOT". DURING F/Y CORRESPONDENCE WITH THE REPORTING FACILITY, THE NURSE INDICATED THAT THE PATIENT WENT INTO SHOCK. THE PATIENT REC'D 70MLS OF INSULIN IN AN INTERVENTION. NURSE IS UNSURE IF THE PATIENT WHEN HYPOGLYCEMIC. THE PATIENT HAS SINCE BEEN MOVED DOWN FROM THE UNIT AND IS NO LONGER IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164929 INFUSOMAT SPACE PUMP SETS WITH ULTRASITE UNIV. 15DROP PUMP SET W/ 2 ULTRASITES FRN B. BRAUN DOMINICAN REPUBLIC NA 0061347781

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R INFUSOMAT SPACE PUMP (CATALOG #8713050U)