BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A, USP

    MDR report key: 8843011 · Received July 30, 2019

    Report

    Report Number
    0001216032-2019-00001
    Event Type
    Injury
    Date Received
    July 30, 2019
    Report Date
    July 25, 2019
    Manufacturer
    CITRA LABS, LLC
    Product Code
    KSB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CORRECTIVE ACTION IS REQUIRED FOR THIS EVENT AS IT WAS THE RESULT OF USER ERROR (NOT FOLLOWING THE INSTRUCTIONS FOR USE).THE POTENTIAL MEDICAL CONSEQUENCES AND SEVERITY OF THIS EVENT (E.G.. CITRATE TOXICITY). INCLUDING ANY MITIGATION (MONITOR THE PATIENT'S IONIZED CALCIUM LEVELS AND INFUSION OF CALCIUM). IS BASED ON AMOUNT INFUSED. CITRATE IS RAPIDLY METABOLIZED IN VIVO WITH A REPORTED HALF-LIFE OF 1.5 MINUTES;THEREFORE BASED ON THE VERY LOW DOSE OF CITRATE INFUSED TO THIS PATIENT NO ADVERSE REACTION WOULD BE EXPECTED. THIS IS CONSISTENT WITH WHAT WAS REPORTED BY THE PHARMACIST IN THIS PATIENT, THE AMOUNT OF CITRATE THAT WAS INJECTED (1.2 ML OR 0.026 GRAMS OF TOTAL CITRATE, EXPRESSED AS CITRIC ACID) WAS COMPARED TO THE AMOUNT CONTAINED IN A UNIT ·OF WHOLE BLOOD (500 ML), WHICH IS COLLECTED INTO 67 ML OF A CITRATE-BASED ANTICOAGULANT (OR APPROXIMATELY 1.45 GRAMS OF TOTAL CITRATE EXPRESSED AS CITRIC ACID). THE AMOUNT OF TOTAL CITRATE CONTAINED IN A STANDARD TRANSFUSED UNIT OF WHOLE BLOOD IS APPROXIMATELY 55 TIMES GREATER THAN THE DOSE (1.2 ML) THAT THIS PATIENT RECEIVED. INFORMATION REGARDING RISK HAZARDS AND ANALYSIS CAN BE FOUND IN THE ACD-A TECHNICAL FILE REVISION 15 DATED 15SEP2017. EVEN THOUGH THERE WAS NO SERIOUS INJURY REPORTED AND THE INVESTIGATION DOES NOT IDENTIFY RISK TO THE PATIENT, THERE WAS A USER ERROR ON THE PART OF THE ATTENDING PHYSICIAN. THIS DECISION TREE WAS REOPENED IN JUNE OF 2019 BASED ON AN INDEPENDENT REVIEW OF THE COMPLAINT AND THE CIRCUMSTANCES SURROUNDING THE EVENT .ALTHOUGH THE PATIENT WAS MONITORED AND DID NOT SHOW ANY SIGNS OR SYMPTOMS OF CITRATE TOXICITY OR EXPERIENCE ANY OTHER ADVERSE EVENT, WE BELIEVE THAT THE USER ERROR OF DIRECT INFUSION BY THE ATTENDING PHYSICIAN AGAINST THE INSTRUCTIONS FOR USE WARRANTS AN ADVERSE EVENT REPORTING.

    Description of Event or Problem · 1

    CITRA LABS RECEIVED A PHONE CALL INQUIRY ON 01 MAY 2018 FROM (B)(6) (PHARMACIST) TO INFORM CITRA THAT THE END USER ACCIDENTALLY INFUSED 1.2 ML OF ACD-A (IV) INTO A PATIENT AND WAS ASKING FOR INFORMATION REGARDING HOW TO MONITOR THE PATIENT. THE PHONE CALL ON 01 MAY 2018 WAS VERY BRIEF BECAUSE THE PHARMACIST WANTED TO RELAY THE INFORMATION BACK TO THE TREATING PHYSICIAN. THE PHARMACIST INDICATED THAT SHE WOULD CALL BACK TO PROVIDE FURTHER DETAILS; HOWEVER NEVER CALLED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634818 ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A, USP ACD-A KSB CITRA LABS, LLC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other