BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5" (13 CM) BAG SPIKE ADAPTER W/SPIROS® W/RED CAP, VENTED CAP

    MDR report key: 9516637 · Received December 24, 2019

    Report

    Report Number
    9617594-2019-00431
    Event Type
    Malfunction
    Date Received
    December 24, 2019
    Date of Event
    December 16, 2019
    Report Date
    December 17, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION, HOWEVER, A VERY SMALL PHOTOGRAPH WAS RETURNED IDENTIFYING THE SEPARATION AT THE BOND INTERFACE BETWEEN THE FEMALE LUER OF THE SPINNING SPIROS AND THE MALE LUER OF THE X1-4736 SUB-ASSEMBLY OF THE CH3034. BASED ON PRIOR COMPLAINTS THIS COMPLAINT IS CONFIRMED. THE PROBABLE CAUSE IS AN INSUFFICIENT BOND DURING MANUAL ASSEMBLY IN ENSENADA. THE DEVICE HISTORY REVIEWS FOR LOTS 4080722 AND 4104223 WERE REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION IN H3 AND H6.

    Additional Manufacturer Narrative · 1

    PLOTS: LOT# 4080722, MFR DATE 2019-05-01, EXPIRATION DATE 2024-05-01; LOT# 4104223, MFR DATE 2019-05-01, EXPIRATION DATE 2024-05-01. THE DEVICE WAS DISCARDED. THERE ARE NO SISTER SAMPLES AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE EVENT INVOLVES A BAG SPIKE ADAPTER W/SPIROS S/RED CAP VENTED CAP, CH3034. THE CUSTOMER REPORTED LINE A IS THE ONLY LINE USED AND PRIMED WITH CHEMO. A CH-14, CHEMOCLAVE VENTED BAG SPIKE, WAS INSERTED INTO THE MAB (PEMBRILUZIMAB) AND THE CH3034 ATTACHED TO THE PLUM SET THEN ATTACHED TO THE CH-14 DEVICE. THE NURSE PICKED BOTH ITEMS UP OUT FROM THE TRAY, THE SPIROS DISCONNECTED AND DROPS OF MAB WENT ONTO HER FOREARM AND THE FLOOR. THE AREA WAS WASHED IMMEDIATELY WITH SOAPY WATER PER HOSPITAL PROTOCOL. THE NURSE HAD TACHYCARDIA AND RAISED BLOOD PRESSURE. SHE HAD A RASH ON HER FRONT AND BACK TRUNK THAT WENT UP HER NECK WITH CHEST TIGHTENING. SHE WAS SENT TO A&E (ACCIDENT AND EMERGENCY DEPARTMENT) FOR TREATMENT, WAS PRESCRIBED CETIRIZINE AND PARACETAMOL, AND REFERRED TO OCCUPATIONAL HEALTH. BY 8PM, THE NURSE WAS FEELING MUCH BETTER, OBSERVATIONS BACK TO NORMAL. THE NURSE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT DURING THE EVENT. THE CHEMO SPILL WAS CLEANED UP PER PROTOCOL WITH A SPILL KIT. THERE WAS A DELAY OF THERAPY FOR 30 MINUTES WITH NO EFFECT ON THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310724 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS® W/RED CAP, VENTED CAP CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CH3034 PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOCLAVE VENTED BAG SPIKE, CH-14.| PEMBRILUZIMAB, UNK MFR.| PLUM SET.