BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, NON-VENT

    MDR report key: 19198774 · Received April 26, 2024

    Report

    Report Number
    9615050-2024-00338
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 26, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, TESTING HAS NOT YET BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE EVENT RELATED TO ¿CASSETTE FAILURE¿ WAS ANALYZED AND ACCORDING TO THE ASSESSMENT PERFORMED IT WAS DETERMINED THAT THIS EVENT WAS NOT CAUSED DURING THE MANUFACTURING PROCESS BECAUSE OF THE FOLLOWING PROBABLE CAUSES: 1- CASSETTE WARPAGE: SINCE THE MEASURE OF WARPAGE EXCEEDS 0.005 INCHES, THE CASSETTES ARE CONSIDERED AS WARPAGE. THIS DEFORMATION WAS NOT CAUSED DURING THE MANUFACTURING PROCESS BECAUSE THE PRODUCTION FLOOR HAS CONTROLLED TEMPERATURE CONDITIONS; FOR THAT REASON, THE MANUFACTURING PROCESS WAS DISCARDED AND THE PROBABLE CAUSE OF WARPAGE IS CAUSED BY EXPOSURE TO EXCESSIVE HEAT DURING TRANSPORTATION. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED, AND THE PROBABLE CAUSE OF THE CASSETTE'S FAILURE IS DUE TO THE WARPAGE OF THE CASSETTE BY EXPOSURE TO EXCESSIVE HEAT DURING TRANSPORTATION. A BATCH RECORD REVIEW WAS PERFORMED ON THE FINAL JOB NUMBER 5935503, LIST NUMBER 142129291 AND IT WAS MANUFACTURED BETWEEN 06/28/2022 TO 07/18/2022 AND THE VISUAL AND PHYSICAL EVALUATION PERFORMED BY MANUFACTURING QUALITY (MQ) INDICATES THAT THE PRODUCT MET THE SPECIFICATION REQUIREMENTS, AND NO SIMILAR DEFECTS WERE FOUND. THE LOT HISTORY WAS REVIEWED, AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. D4 - PRIMARY UDI NUMBER: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 41 CM (16") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), VENTED CAP GENERATED A BREAK DURING PATIENT USE. THE REPORTER STATED "DESCRIPTION OF THE EVENT AS REPORTED: NON-CHEMOTHERAPY AND NORMAL SALINE CONNECTED VIA SPIKE AND LINE (BIFUSE). THE NURSE TOUCHED THE LINE TO THE NORMAL SALINE BAG WHICH DISCONNECTED FROM THE SPIKE. NORMAL SALINE THEN LEAKED ONTO THE FLOOR, WHILST THE INFUSION KEPT RUNNING. INFUSION COMPLETED; NON-CHEMOTHERAPY BAG REPLACED WITH NORMAL SALINE FOR A FLUSH. TREATMENT COMPLETED". THE SET WAS USED FOR NON-CHEMOTHERAPY TREATMENT INFUSION. THE ACCOUNT MANAGER ALSO MENTIONED THAT THE SPIKE BROKE OFF. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839956 PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, NON-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 5935503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown