BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SETS (M & ST)

    MDR report key: 16627699 · Received March 28, 2023

    Report

    Report Number
    8010182-2023-00088
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Report Date
    April 25, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    UDI-DI
    07332414064556
    PMA / PMN Number
    K041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO: G4 (K041005 NOT NA). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. DURING AN AIR LEAK TEST, A LEAK WAS OBSERVED AT THE LEVEL OF THE FILTER DUE TO A CRACK. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. HOWEVER, THE MOST PROBABLE CAUSE WAS DUE TO SHOCK DURING SHIPPING. THE OBSERVED DAMAGE IS TYPICAL OF MECHANICAL SHOCK APPLIED ON THE PRODUCT LEADING TO ITS BREAKAGE. THE EXACT MOMENT AND LOCATION WHERE THE SHOCK OCCURRED COULD NOT BE DETERMINED. A PRODUCT WITH SUCH DAMAGE WOULD HAVE BEEN DETECTED DURING THE MANUFACTURING PLANT¿S 100% IN PROCESS VISUAL CONTROL & LEAK TEST. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRIMING, AN EXTERNAL LEAK WAS OBSERVED IN A PRISMAFLEX M100 SET DUE TO A CRACK IN THE FILTER. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10565 PRISMAFLEX SETS (M & ST) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA 22E0093 07332414064556

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PRISMAFLEX MACHINE