BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP37

    MDR report key: 22715133 · Received August 5, 2025

    Report

    Report Number
    3016746283-2025-00006
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 14, 2025
    Report Date
    November 7, 2025
    Manufacturer
    SPECTRUM MEDICAL S.R.L.
    Product Code
    KFM
    UDI-DI
    08051160300617
    PMA / PMN Number
    K202169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINED DEVICE DUE TO ITS DISPOSAL BY THE HOSPITAL, IF THE REPORTED PROBLEM WERE TO BE CONFIRMED, THIS WOULD BE THE THIRD SIMILAR CASE RECEIVED. NEVERTHELESS, AS THIS IS AN ISSUE DETECTABLE DURING THE PRIMING PHASE BEFORE THE PATIENT INVOLVEMENT, AND THE FACT THAT CURRENTLY HAS AN INCIDENCE OF (B)(4) COMPARED TO THE NUMBER OF CP37V-V0 DEVICES SOLD IN 2025, IT IS DEEMED NOT NECESSARY TO TAKE FURTHER ACTION. THE HEALTH EFFECT CLINICAL CODE ASSIGNED REPRESENTS A WORST-CASE SCENARIO WITH RESPECT TO THE PRESENT EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER INVESTIGATION OF RETURNED DEVICE, WHICH COULD BE ADDRESSED IN A FOLLOW-UP REPORT. BECAUSE THE ISSUE WAS DETECTED DURING THE DEVICE PRIMING PHASE, THE PATIENT WAS NOT INVOLVED; MOREOVER, THE HEALTH EFFECT CLINICAL CODE ASSIGNED REPRESENTS A WORST-CASE SCENARIO WITH RESPECT TO THE PRESENT EVENT.

    Description of Event or Problem · 0

    CP37 PUMPHEAD CAVITATING SIGNIFICANT AIR DURING PRIMING. IT WAS DEAIRED MULTIPLE TIMES BUT IT CONTINUED TO ENTRAIN AIR. NO NOISE OR CRACKS/VISIBLE DAMAGE TO PUMPHEAD. PRESSURIZED CIRCUIT TO TEST FOR LEAK, BUT NO LEAK NOTED. SWAPPED OUT FOR NEW PUMPHEAD AND THE ISSUE DISAPPEARED.

    Description of Event or Problem · 0

    CP37 PUMPHEAD CAVITATING SIGNIFICANT AIR DURING PRIMING. IT WAS DEAIRED MULTIPLE TIMES BUT IT CONTINUED TO ENTRAIN AIR. NO NOISE OR CRACKS/VISIBLE DAMAGE TO PUMPHEAD. PRESSURIZED CIRCUIT TO TEST FOR LEAK, BUT NO LEAK NOTED. SWAPPED OUT FOR NEW PUMPHEAD AND THE ISSUE DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2634262 QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP37 CENTRIFUGAL BLOOD PUMP KFM SPECTRUM MEDICAL S.R.L. CP37V-V0 G001836 08051160300617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention