BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUHRMAN PLEURAL & PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 832529 · Received March 29, 2007

    Report

    Report Number
    1820334-2007-00069
    Event Type
    Injury
    Date Received
    March 29, 2007
    Date of Event
    January 2, 2006
    Report Date
    February 27, 2007
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: NO PRODUCT OR LOT NUMBER INFO WAS PROVIDED. HOWEVER, BASED ON THE INFO PROVIDED, THIS INCIDENT APPEARS TO BE THE RESULT OF PROCEDURALLY RELATED CIRCUMSTANCES BEYOND THE CONTROL. WE DO STATE IN OUR INSTRUCTIONS FOR USE BOOKLET; "THE PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD SELDINGER TECHNIQUE FOR PLACEMENT OF NEEDLES, WIRE GUIDES, DILATORS, AND CATHETERS SHOULD BE EMPLOYED." WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED IN A JOURNAL ARTICLE. RW BROOKER, GR BOOTH, DE DEMELLO, AND WJ KEENAN. "UNSUSPECTED TRANSECTION OF LUNG BY PIGTAIL CATHETER IN A PREMATURE INFANT." JOURNAL OF PERINATOLOGY (2007) 27:190-192. AN INFANT WAS BORN FOLLOWING A DIAMIONIC-MONOCHORIONIC TWIN PREGNANCY AND WAS THE DONOR IN A TWIN-TWIN TRANSFUSION. THE MOTHER WAS HOSPITALIZED BECAUSE OF PRETERM LABOR. A CESAREAN SECTION WAS PERFORMED 6 WEEKS LATER BECAUSE OF FETAL COMPROMISE. DELIVERY ROOM RESUSCITATION CONSISTED OF BAG MASK BREATHS AND ORAL SUCTIONING. SHE REQUIRED INTUBATION SECONDARY TO RESPIRATORY INSUFFICIENCY. PULMONARY SURFACTANT WAS GIVEN. HIGH-FREQUENCY OSCILLATOR VENTILATION WAS INITIATED FOR POOR VENTILATION. CHEST RADIOGRAPHS WERE ORDERED EVERY 8H AS SURVEILLANCE OF LUNG INFLATION. A CHEST RADIOGRAPH 3 DAYS LATER SHOWED A RIGHT SIDED PNEUMOTHORAX WITH SHIFT IN THE MEDIASTINUM TO THE LEFT. A MODIFIED FUHRMAN THORACOSTOMY CATHETER WAS INSERTED BY SELDINGER TECHNIQUE, AS DESCRIBED BY FUHRMAN, ET AL. WITH RESOLUTION OF THE PNEUMOTHORAX CONFIRMED BY RADIOGRAPH. BREATH SOUNDS WERE DOCUMENTED AS EQUAL UNTIL THE TIME OF DEATH. THE FRACTION OF INSPIRED OXYGEN AND THE MEAN AIRWAY PRESSURE (MAP) WERE DECREASED OVER THE NEXT 24 HRS. REPEATED RADIOGRAPHS SHOWED NO SIGNS OF PNEUMOTHORAX. HER CLINICAL COURSE DETERIORATED THE FOLLOWING DAY WITH WORSENING HYPOTENSION, HYPOXEMIA, METABOLIC ACIDOSIS AND RENAL FAILURE. DESPITE INTENSE SUPPORT, SHE REMAINED PROFOUNDLY ACIDOTIC AND, AFTER CONSULTATION WITH THE FAMILY, SUPPORT WAS WITHDRAWN. AN AUTOPSY WAS PERFORMED WITH THE THORACOSTOMY TUBE UNDISTURBED. THE CATHETER TRAVERSED THE CHEST WALL, ENTERED THE VENTRAL SURFACE AND EXITED THE DORSAL SURFACE OF THE RIGHT LOBE. PULMONARY HYPOPLASIA WAS CONFIRMED. THE COMBINED LUNG WEIGHT WAS 17G (EXPECTED WEIGHT: 28G). PREACINAR ARTERIES WERE OF SMALL CALIBER. THE RADIAL ALVEOLAR COUNT WAS 2-3 (EXPECTED COUNT: GREATER THAN FOUR). FOCAL HYALINE MEMBRANES WERE PRESENT LINING DISTAL AIR PASSAGES AND THE LUNGS WERE IMMATURE. THE KIDNEYS' COMBINED WEIGHT WAS 10G (EXPECTED WEIGHT 12.5G). THERE WERE NO INFLAMMATORY OR DEGENERATIVE CHANGES OF THE RENAL CORTEX. THERE WAS NO CONGESTION OF THE VASA RECTA. OTHER FINDINGS INCLUDED THYMICINVOLUTION, SMALL ADRENAL GLANDS (COMBINED WEIGHT 1G, EXPECTED WEIGHT 4.2G) AND A PORENCEPHALIC DEFECT OF THE RIGHT FRONTAL-PARIETAL CORTEX OVER THE DORSAL CONVEXITIES OF THE BRAIN. EXAMINATION OF THE PLACENTA CONFIRMED THE VASCULAR ANASTOMOSES AND AMNIONNODOSUM WAS NOTED IN THE AMNIOTIC CASE OF THIS INFANT. CHROMOSOME ANALYSIS REVEALED A KARYOTYPE OF 46, XX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUHRMAN PLEURAL & PNEUMOPERICARDIAL DRAINAGE SET DQY SPECIAL SET DQY COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DAY Required Intervention