BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 15212477 · Received August 11, 2022

    Report

    Report Number
    1820334-2022-01334
    Event Type
    Death
    Date Received
    August 11, 2022
    Report Date
    January 16, 2023
    Manufacturer
    COOK INC
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER: DR. RW BROOKER, DEPARTMENT OF PEDIATRICS, DIVISION OF NEONATOLOGY, CARDINAL GLENNON CHILDREN¿S HOSPITAL, 1465 S. GRAND BLVD., ST LOUIS, MO 63104, USA., E-MAIL: [email protected]. PMA/510K: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    CORRECTION: D - PRODUCT IDENTIFIER, D4 - RPN, H6 - ANNEX A. INVESTIGATION / EVALUATION: (B)(6) HOSPITAL (UNITED STATES) SUBMITTED A JOURNAL ARTICLE CONCERNING A COOK FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET (RPN: C-PPD-850) FROM AN UNKNOWN LOT. A PRE-TERM BABY WAS BORN VIA CESAREAN SECTION BECAUSE OF FETAL COMPROMISE. THE INFANT DEVELOPED BREATHING COMPLICATIONS DUE TO RESPIRATORY INSUFFICIENCY. ON DAY THREE OF LIFE, THE BABY SHOWED A RIGHT SIDED PNEUMOTHORAX WITH A SHIFT IN THE MEDIASTINUM TO THE LEFT. A MODIFIED FUHRMAN THORACOSTOMY CATHETER WAS INSERTED USING SELDINGER TECHNIQUE WITH RESOLUTION OF THE PNEUMOTHORAX CONFIRMED VIA RADIOGRAPH. AN AUTOPSY WAS PERFORMED, AND PULMONARY HYPOPLASIA WAS CONFIRMED. THE CATHETER TRAVERSED THE CHEST WALL, ENTERED THE VENTRAL SURFACE, AND EXITED THE DORSAL SURFACE OF THE RIGHT MIDDLE LOBE. THE PROCEDURE WAS A CATHETER INSERTION FOR TENSION PNEUMOTHORAX. THE DATE OF EVENT IS 29JUN2006 AND COOK BECAME AWARE OF THIS EVENT ON 29JUL2022. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE COMPLETED. HOWEVER, A PHOTO PROVIDED IN THE ARTICLE SHOWED CATHETER MIGRATION. COOK WAS NOT ABLE TO DETERMINE IF THE PRODUCT WAS OUT OF SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT PROCESS CHECKS WERE IDENTIFIED TO PREVENT NONCONFORMING MATERIAL FROM LEAVING HOUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO THE LACK OF LOT INFORMATION PROVIDED IN THE ARTICLE. A SALES REPORT WAS PERFORMED AND REVIEWED. A POSSIBLE LOT NUMBER WAS NOT ABLE TO BE DETERMINED. THE SALES REPORT DID PROVIDE A REAL PART NUMBER, AS ONLY ONE RPN CAME UP FOR THE CUSTOMER. COOK ALSO REVIEWED PRODUCT LABELING. THESE PRODUCTS ARE SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET, C_T_PPD_REV4. IN THE PRECAUTIONS SECTION IT STATES: THE PROCEDURE MAY REQUIRE TWO-DIMENSIONAL ECHOCARDIOGRAPHIC GUIDANCE OR FLUOROSCOPIC CONTROL TO CLOSELY MONITOR THE HEART DURING PLACEMENT INTO THE PERICARDIAL SPACE. A TF-COATED WIRE GUIDE IS RECOMMENDED FOR A SMOOTHER CATHETER INTRODUCTION. 6.) INTRODUCE THE WIRE GUIDE AND GENTLY ADVANCE IT INTO THE SELECTED CAVITY. NOTE: THE WIRE GUIDE SHOULD ADVANCE WITHOUT IMPEDANCE. 7.) REMOVE THE NEEDLE, LEAVING THE WIRE GUIDE IN PLACE, THEN DILATE WITH THE SUPPLIED DILATOR TO FACILITATE CATHETER INTRODUCTION. 8.) INTRODUCE THE CATHETER OVER THE WIRE GUIDE. NOTE: THE WIRE GUIDE SHOULD ALWAYS EXTEND BEYOND THE CATHETER TIP. 9.) ADVANCE THE CATHETER INTO POSITION. REMOVE THE WIRE GUIDE AND ATTACH THE MULTIPURPOSE ADAPTER TO THE CATHETER. IN THE HOW SUPPLIED SECTION IT STATES: UPON REMOVAL FROM PACKAGE, INSPECT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT AN UNINTENDED USER ERROR CONTRIBUTED TO THE REPORTED EVENT. THE CUSTOMER PUNCTURED THE VENTRAL WALL DURING PLACEMENT, THUS LEADING TO THE EVENTUAL DEATH OF THE INFANT. THE PRODUCT IS ALSO NOTED TO HAVE BEEN USED AFTER EXPIRATION DATE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    COOK WAS MADE AWARE OF AN EVENT INVOLVING A COOK FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE CATHETER THAT WAS REPORTED IN A CASE REPORT IN THE JOURNAL OF PERINATOLOGY. BROOKER, R. W., BOOTH, G. R., DEMELLO, D. E., & KEENAN, W. J. (2007). UNSUSPECTED TRANSECTION OF LUNG BY PIGTAIL CATHETER IN A PREMATURE INFANT. JOURNAL OF PERINATOLOGY : OFFICIAL JOURNAL OF THE CALIFORNIA PERINATAL ASSOCIATION, 27(3), 190¿192. HTTPS://DOI.ORG/10.1038/SJ.JP.7211649. THE INFANT WAS BORN FOLLOWING A DIAMNIONIC¿MONOCHORIONIC TWIN PREGNANCY AND SHE WAS THE DONOR IN A TWIN-TO-TWIN TRANSFUSION. THE MOTHER WAS HOSPITALIZED AT 26 WEEKS GESTATION BECAUSE OF PRETERM LABOR. A CESAREAN SECTION WAS PERFORMED AT 32 WEEKS GESTATION BECAUSE OF FETAL COMPROMISE. DELIVERY ROOM RESUSCITATION CONSISTED OF BAG MASK BREATHS AND ORAL SUCTIONING. THE BIRTH WEIGHT WAS 975 GRAMS. 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 8 HOURS AS SURVEILLANCE OF LUNG INFLATION. A CHEST RADIOGRAPH ON THE THIRD DAY AFTER BIRTH 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.,6 WITH RESOLUTION OF THE PNEUMOTHORAX CONFIRMED BY RADIOGRAPH (FIGURE 1). 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 HOURS. 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 ON THE FOURTH DAY AFTER BIRTH. 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 MIDDLE LOBE (FIGURE 2). PULMONARY HYPOPLASIA WAS CONFIRMED. THE COMBINED LUNG WEIGHT WAS 17 GRAMS (EXPECTED WEIGHT: 28 GRAMS). 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 10 GRAMS (EXPECTED WEIGHT 12.5 GRAMS). THERE WERE NO INFLAMMATORY OR DEGENERATIVE CHANGES OF THE RENAL CORTEX. THERE WAS NO CONGESTION OF THE VASA RECTA. OTHER FINDINGS INCLUDED THYMIC INVOLUTION, SMALL ADRENAL GLANDS (COMBINED WEIGHT 1 GRAM, EXPECTED WEIGHT 4.2 GRAMS) 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 AMNION NODOSUM WAS NOTED IN THE AMNIOTIC SAC OF THIS INFANT. CHROMOSOME ANALYSIS REVEALED A KARYOTYPE OF 46, XX.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381237 FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Female Death