BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LILLIPUP PMP, LILLIPUT PMP INTEGRATED

    MDR report key: 14828585 · Received June 27, 2022

    Report

    Report Number
    9680841-2022-00029
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    May 16, 2022
    Report Date
    August 26, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE COMPLAINED LILLIPUT ECMO OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (CATALOGUE C20094ND, LOT 2111090100) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. THE COMPLAINED LILLIPUT ECMO OXYGENATOR IS SIMILAR TO THE LILLIPUP PMP, LILLIPUT PMP INTEGRATED OXYGENATOR CATALOGUE 050577, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS 0803317811275. THE COMPLAINED LILLIPUT ECMO OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA AND SIMILAR TO THE LILLIPUP PMP, LILLIPUT PMP INTEGRATED OXYGENATOR CATALOGUE 050577, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K151713). THE DEVICE MANUFACTURING DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE LILLIPUT ECMO OXYGENATOR. THE INCIDENT OCCURRED IN PARIS, FRANCE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN DISPOSED BY THE CUSTOMER. LIVANOVA IS FOLLOWING UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION ON ECMO PROCEDURE DATA. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA HAS RECEIVED A REPORT THAT, DURING SUPPORT, AFTER NEARLY ONE DAY FROM CHANGE-OUT, THE PATIENT BLOOD OXYGEN SATURATION WAS 40% PRE-OXYGENATOR AND 70% POST-OXYGENATOR USING A LILLIPUT ECMO OXYGENATOR. MEDICAL TEAM ELECTED TO THE CHANGE OUT THE OXYGENATOR, ADMINISTER HETEROLOGOUS BLOOD TO THE PATIENT. ACCORDING TO INFORMATION, THE ISSUE CAUSED TRANSIENT HYPOXIA. THERE IS NO REPORT OF ANY PATIENT INJURY. THE INVOLVED DEVICE WAS NOT MADE AVAILABLE FOR RETURN AND INVESTIGATION, SINCE IT HAS BEEN DISPOSED BY THE CUSTOMER. VERIFICATION OF MANUFACTURING RECORDS POINTED OUT THAT NOTICED DEVICE WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. REVIEW OF COMPLAINTS DATABASE REVEALED NO OTHER SIMILAR CASES NOTIFIED FOR BATCH CONCERNED FROM THE MARKET. ON JULY 28TH, 2022, DURING A FOLLOW UP COMMUNICATION WITH THE CUSTOMER, IT WAS LEARNT THAT: THE PATIENT WAS FINE AFTER THE INCIDENT AND DIED FEW DAYS AFTER FOR OTHER REASONS; THE CHANGE-OUT OF THE OXYGENATOR LAST ABOUT 15 MINUTES; THE OXYGENATOR CHANGE-OUT DID NOT IMPROVE THE GAS-BLOOD PARAMETERS. THE PUMP SHEET OF THE CASE WAS NOT MADE AVAILABLE TO ANALYZE THE INITIAL GAS-BLOOD PARAMETERS APPLIED BY MEDICAL TEAM AND ANY SUBSEQUENT ADJUSTMENT PRIOR TO REPLACING THE DEVICE. DURING THE FOLLOW-UP WITH THE CUSTOMER ON JULY 28TH, 2022, THE MEDICAL TEAM CONFIRMED THAT THERE WAS NOT A RELATIONSHIP BETWEEN THE REPORTED LOW OXYGENATION CONDITION AND THE DEVICE. CONSEQUENTLY, THERE IS NO DIRECT RELATIONSHIP BETWEEN THE PATIENT OUTCOME AND ANY DEVICE-RELATED MALFUNCTION. ACCORDING TO THE MEDICAL TEAM, THE REPORTED EVENT WAS SOLELY DUE TO THE PATIENT CLINICAL CONDITIONS. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET. H3 OTHER TEXT : DISPOSED BY THE CUSTOMER.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING SUPPORT, AFTER NEARLY ONE DAY FROM CHANGE-OUT, THE PATIENT BLOOD OXYGEN SATURATION WAS 40% PRE-OXYGENATOR AND 70% POST-OXYGENATOR USING A LILLIPUT ECMO OXYGENATOR. MEDICAL TEAM ELECTED TO THE CHANGE OUT THE OXYGENATOR, ADMINISTER HETEROLOGOUS BLOOD TO THE PATIENT. ACCORDING TO INFORMATION, THE ISSUE CAUSED TRANSIENT HYPOXIA. THERE IS NO REPORT OF ANY PATIENT INJURY. ON (B)(6) 2022, DURING FOLLOW UP WITH THE CUSTOMER, IT WAS CONFIRMED THE PATIENT IS FINE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055602 LILLIPUP PMP, LILLIPUT PMP INTEGRATED OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2110200044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown