BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 21720227 · Received March 28, 2025

    Report

    Report Number
    1314417-2025-00021
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Report Date
    May 22, 2025
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CCK
    UDI-DI
    00810071631863
    PMA / PMN Number
    K063813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 28 MAR 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    CORRECTION: G1. ADDITIONAL INFORMATION: D4; H6. VIDEO EVIDENCE PROVIDED BY THE REPORTER WAS REVIEWED AND CONFIRMED THE EVENT AS REPORTED. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR. THE DEVICE HISTORY RECORD FOR LOT 240100249 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 22 MAY 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE FIFTH OF SIX REPORTS. REFER TO 1314417-2025-00017 FOR THE FIRST REPORT. REFER TO 1314417-2025-00018 FOR THE SECOND REPORT. REFER TO 1314417-2025-00019 FOR THE THIRD REPORT. REFER TO 1314417-2025-00020 FOR THE FOURTH REPORT. REFER TO 1314417-2025-00022 FOR THE SIXTH REPORT. IT WAS REPORTED, WHEN THE ZOLL MONITOR WAS APPLIED TO THE NON- INTUBATED PATIENT NO DATA DISPLAYED (NO READING AND/ OR RESPIRATORY RATE), WHICH LEAD TO A DELAY AND DIFFICULTY IN GATHERING VITAL SIGNS TO ASSESS BREATHING. THE CAPNO LINES WERE CHANGED; THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE FIFTH OF SIX REPORTS. REFER TO 1314417-2025-00017 FOR THE FIRST REPORT, REFER TO 1314417-2025-00018 FOR THE SECOND REPORT, REFER TO 1314417-2025-00019 FOR THE THIRD REPORT, REFER TO 1314417-2025-00020 FOR THE FOURTH REPORT, REFER TO 1314417-2025-00022 FOR THE SIXTH REPORT. IT WAS REPORTED, WHEN THE ZOLL MONITOR WAS APPLIED TO THE NON- INTUBATED PATIENT NO DATA DISPLAYED (NO READING AND/ OR RESPIRATORY RATE), WHICH LEAD TO A DELAY AND DIFFICULTY IN GATHERING VITAL SIGNS TO ASSESS BREATHING. THE CAPNO LINES WERE CHANGED; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693350 CURAPLEX ADULT 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTER CCK BOUND TREE MEDICAL, LLC 5107ET 240100249 00810071631863

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown