BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAS KIDS D100 NEONATAL OXY

    MDR report key: 2062758 · Received April 8, 2011

    Report

    Report Number
    1718850-2011-00020
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K061031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE KIDS D100 OXYGENATOR IS MFG BY SORIN GROUP (B)(4). THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE PERFUSIONIST REPORTED THE D100, RATED UP TO 5 KG, WAS USED ON A 7 KG PT. AT THE START OF BYPASS, THE VENOUS SATURATION DROPPED FROM 72 TO 60. THE OXYGENATOR WAS REPLACED WITH A D101, USED ON PTS LARGER THAN 5 KG. THE CASE CONTINUED WITHOUT ISSUE. ALL SATURATIONS WERE NORMAL. THE D100 WAS RETURNED TO SORIN GROUP USA FOR EVAL. VISUAL INSPECTION DID NOT REVEAL ANY DEFECTS. THE DEVICE WAS SUBJECTED TO OXYGEN (PO2) AND CARBON DIOXIDE (PCO2) GAS TRANSFER TESTING. A CONTROL UNIT WAS TESTED FOR COMPARISON. THE RETURNED D100 PCO2 AND PO2 GAS TRANSFER VALUES WERE SLIGHTLY LOWER BUT COMPARABLE TO THAT OF THE CONTROL. THE LOWER VALUES ARE USUALLY SEEN WITH UNITS THAT HAVE BEEN EXPOSED TO BLOOD DURING A CASE. LAB TESTING SHOWED THE RETURNED D100 WAS COMPARABLE TO THE CONTROL. THE OXYGENATOR WAS FUNCTIONALLY SOUND AND CAPABLE OF MEETING METABOLIC DEMANDS FOR THE INTENDED USE. IT IS FEASIBLE THAT THE REPORTED PROBLEM WAS DUE TO USING AN OXYGENATOR OUTSIDE OF THE RATED USE. THE INSTRUCTIONS FOR USE STATE THAT THE D100 KIDS NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR IS INTENDED FOR USE IN INFANTS WHO UNDERGO CARDIOPULMONARY BYPASS SURGERY REQUIRING EXTRACORPORAL CIRCULATION WITH A MAXIMUM BLOOD FLOW RATE OF 0.7 LITERS/MINUTE. THE D101 INSTRUCTIONS FOR USE STATE THAT THE D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR IS INTENDED FOR USE IN INFANTS WHO UNDERGO CARDIOPULMONARY BYPASS SURGERY REQUIRING EXTRACORPOREAL CIRCULATION WITH A MAXIMUM BLOOD FLOW RATE OF 2.5 LITERS/MINUTE. THERE WAS NO REPORT OF PT INJURY. A UNIT OF BLOOD WAS GIVEN TO COMPENSATE FOR THE BLOOD LOSS WHEN THE OXYGENATOR WAS CHANGED OUT. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THE D100 RATED UP TO 5 KG, WAS USED ON A 7 KG PT. AT THE START OF BYPASS, THE VENOUS SATURATION DROPPED FROM 72 TO 60. THE OXYGENATOR WAS REPLACED WITH A D101, USED ON PTS LARGER THAN 5 KG. THE CASE CONTINUED WITHOUT ISSUE. ALL SATURATIONS WERE NORMAL. A UNIT OF BLOOD WAS GIVEN TO COMPENSATE FOR THE BLOOD LOST IN THE OXYGENATOR SYSTEM. IT WAS REPORTED THAT THE PT WAS DOING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS KIDS D100 NEONATAL OXY OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1007130097

    Patients

    Seq Age Sex Outcome Treatment
    1