BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 10102594 · Received May 29, 2020

    Report

    Report Number
    9616066-2020-01583
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 4, 2020
    Report Date
    May 6, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, D.10 RETURNED TO MANUFACTURER ON: 06/01/2020. INVESTIGATION CONCLUSION THIRTY EIGHT (38) MP1000C-0006 SAMPLES WERE RECEIVED FOR INVESTIGATION; THIRTY SIX FROM MULTIPLE LOT NUMBERS WERE RECEIVED INSIDE THE SEALED PACKAGING AND TWO WERE RECEIVED WITHOUT PACKAGING WITH RESIDUAL FLUID CONTAINED INSIDE. ADDITIONALLY ONE MP1000C FROM LOT 17045985 WAS RECEIVED IN SEALED PACKAGING TO ASSIST THE INVESTIGATION. A VISUAL INSPECTION OF THE SAMPLES RECEIVED WITHOUT PACKAGING IDENTIFIED A CRACK TO THE HOUSING OF THE MAXPLUS RUNNING ALONG THE MIDDLE OF THE COMPONENTS; LEAKAGE WAS OBSERVED FROM THE CRACK DURING A FLUSH THROUGH. A VISUAL INSPECTION OF ALL THE REMAINING SAMPLES DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS. FURTHERMORE, FUNCTIONAL TESTING WAS PERFORMED ON ALL THESE SAMPLES BY APPLYING PRESSURED WATER; NO LEAKAGE OR SIMILAR ISSUES WERE IDENTIFIED DURING TESTING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE OBSERVED DAMAGE IS CONSISTENT WITH THE COMPONENT HAVING BEEN SUBJECTED TO AN EXTERNAL FORCE. ANALYSIS OF THE ASSEMBLY PROCESS IDENTIFIED THE DAMAGE COULD HAVE BEEN MADE BY THE CUTTING RAZORS DURING THE FINAL STAGE OF THE PACKAGING SEALING PROCESS DUE TO POTENTIAL SAMPLE ACCUMULATION. IF THIS OCCURS THE MACHINE IS PROGRAMMED TO STOP AUTOMATICALLY SO THE OPERATOR CAN SEGREGATE THE MATERIAL MANUALLY. IN THIS INSTANCE IT IS LIKELY THE AFFECTED SAMPLES WERE NOT CORRECTLY SEGREGATED DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FOR THE LOTS RECEIVED DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT IN ORDER TO BE AWARE OF THE REPORTED FEEDBACK DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH ONE REPORT OF THIS NATURE AGAINST THE MAXPLUS PRODUCT IN THE PAST 12 MONTHS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXPLUS CLR POSITIVE DISPLACEMENT CONN APPEARED TO BE CRACKED, AND LEAKED DURING USE WHEN PRIMED AND CONNECTED TO THE CENTRAL FEEDING LINE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT APPEARED TO BE CRACKED AND LEAKED DURING PRIMING OF FEEDING LINE. THE PARENT OF A CHILD USING TPN AT HOME USING A CENTRAL LINE, REPORTED THAT 3 CONNECTORS WERE CRACKED AND LEAKING WHEN PRIMED AND CONNECTED TO HER CHILD'S CENTRAL LINE."

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # [17045985] WAS NOT FOUND FOR THE REPORTED CATALOG # [MP1000C-0006]. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 19116570, MEDICAL DEVICE EXPIRATION DATE: 11/24/2024, DEVICE MANUFACTURE DATE: 11/16/2019. MEDICAL DEVICE LOT #: 19126246. MEDICAL DEVICE EXPIRATION DATE: 12/17/2024. DEVICE MANUFACTURE DATE: 12/11/2019. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXPLUS CLR POSITIVE DISPLACEMENT CONN APPEARED TO BE CRACKED, AND LEAKED DURING USE WHEN PRIMED AND CONNECTED TO THE CENTRAL FEEDING LINE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT APPEARED TO BE CRACKED AND LEAKED DURING PRIMING OF FEEDING LINE THE PARENT OF A CHILD USING TPN AT HOME USING A CENTRAL LINE, REPORTED THAT 3 CONNECTORS WERE CRACKED AND LEAKING WHEN PRIMED AND CONNECTED TO HER CHILD'S CENTRAL LINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565683 MAXPLUS CLR POSITIVE DISPLACEMENT CONN INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV MP1000C-0006 SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(6) 2020.| (B)(6) 2020.