BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7318679 · Received March 6, 2018

    Report

    Report Number
    2210968-2018-71304
    Event Type
    Injury
    Date Received
    March 6, 2018
    Report Date
    February 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/9/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: PEDIATR SURG INT. 2011; 27:811¿815. DOI: 10.1007/S00383-011-2890-8. (B)(4)

    Description of Event or Problem · 1

    LITERATURE ARTICLE: PREDICTORS OF PROLONGED DRAINAGE OF CHYLOTHORAX AFTER CARDIAC SURGERY: SINGLE CENTRE STUDY. CHYLOTHORAX IS MAINLY A POST-OPERATIVE COMPLICATION, ESPECIALLY POST-CARDIOTHORACIC INTERVENTIONS OR SURGERIES OR CAUSED BY SUBCLAVIAN VEIN THROMBOSIS. IT IS RARELY CONGENITAL OR SYNDROMIC IN ORIGIN. IT WAS REPORTED THAT CHYLOTHORAX POST-CARDIAC SURGERY IS DUE TO DIRECT INJURY TO THE THORACIC DUCT, CENTRAL VENOUS THROMBOSIS, AND/OR HIGH CENTRAL VENOUS PRESSURE. THIS RETROSPECTIVE STUDY AIMS TO DETERMINE THE PREDICTORS OF PROLONGED DRAINAGE OF CHYLOTHORAX AFTER CARDIAC SURGERY FOR MORE THAN 21 DAYS IN A SINGLE TERTIARY CENTER. THE AUTHOR REPORTED A TOTAL OF 52 CASES OF CHYLOTHORAX POST-CARDIAC SURGERIES (28 FEMALES AND 24 MALES). BOTH PLEURAE ARE ROUTINELY OPENED AND DRAINED BY SILASTIC BLAKE DRAINS. TREATMENT INCLUDED DIETARY MODIFICATION WITH FAT-FREE DIET, MONOGEN WITH DIURESIS, AND ANGIOTENSIN CONVERTING ENZYMES (ACE) INHIBITORS. THE MEDIAN DURATION OF THE CHEST TUBE DRAINAGE WAS 4 TO 34 DAYS. RESULTS SHOWED THAT 36 PATIENTS RESPONDED TO LONE FAT-FREE DIET, 7 PATIENTS RESPONDED TO FAT-FREE DIET PLUS STEROIDS REGIMEN, 4 PATIENTS RESPONDED TO FAT FREE DIET PLUS OCTREOTIDE REGIMEN, AND 3 PATIENTS RESPONDED TO FAT-FREE DIET, STEROIDS, AND OCTREOTIDE REGIMEN. THERE ARE 2 PATIENTS WHO DID NOT DID NOT RESPOND TO THE CONSERVATIVE TREATMENT. ONE PATIENT WAS A (B)(6) BOY WITH A DOUBLE OUTLET HYPOPLASTIC RIGHT VENTRICLE WHO HAD REDO STERNOTOMY AND BIDIRECTIONAL GLENN SHUNT STATUS POST-BLALOCK¿TAUSSIG SHUNT AND THROMBOSIS OF THE LEFT FEMORAL VEIN. MONOGEN REGIMEN WAS STARTED FOR 10 DAYS, FOLLOWED BY STEROIDS TREATMENT FOR 5 DAYS. HOWEVER, THE CHEST TUBE DRAINAGE CONTINUED PROFUSELY. BECAUSE OF THE NON COMPLIANCE OF THE MOTHER WHO KEPT ON GIVING MILK FORMULA, THE PATIENT UNDERWENT RIGHT THORACOTOMY AND SUPRA-DIAPHRAGMATIC LIGATION OF THE THORACIC DUCT. THE PATIENT¿S CHEST TUBE WAS REMOVED 6 DAYS POST-DUCT LIGATION. THE OTHER PATIENT WAS (B)(6) MALE WITH DIABETES, HYPERTENSION, DYSLIPIDEMIA, THREE VESSEL CORONARY ARTERY DISEASE, AND CHRONIC RENAL IMPAIRMENT. THE PATIENT UNDERWENT CABG. POST-OPERATIVELY, HE STARTED TO DEVELOP OBVIOUS CHYLOTHORAX SEPSIS, MULTI-ORGAN FAILURE, AND PROLONGED ICU STAY. THE PATIENT DIED 24 DAYS POST-OPERATIVE DAY. IT WAS REPORTED THAT ADMINISTRATION OF A HIGH-FAT MEAL BY MOUTH OR VIA A NASOGASTRIC TUBE WILL RESULT IN A DRAMATIC CHANGE IN THE COLOR, TRIGLYCERIDE, AND CHYLOMICRON CONTENT OF THE PLEURAL EFFUSION, CONFIRMING THE PRESENCE OF CHYLE LEAK. CONSERVATIVE THERAPY OF CHYLOTHORAX AFTER CARDIAC SURGERY REMAINS THE STANDARD APPROACH IN MOST CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159451 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention