BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 7185092 · Received January 12, 2018

    Report

    Report Number
    1820334-2018-00068
    Event Type
    Death
    Date Received
    January 12, 2018
    Date of Event
    January 24, 2015
    Report Date
    April 19, 2018
    Manufacturer
    COOK INC
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWING, INSTRUCTION FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CLINICAL ASSESSMENT CANNOT ELIMINATE POSSIBLE CAUSES FOR THIS EVENT SUCH AS MEDICAL PROCEDURE, USER TECHNIQUE, HUMAN ANATOMY, DEVICE SELECTION, LABELING OR DISEASE PROGRESSION RELATED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS EVENT ISSUE HAS BEEN ESCALATED PER INTERNAL PROCESSES.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: (B)(6). (B)(4). PMA/510(K) #: EXEMPT. THE DEVICE IS PACKAGED WITH IFU C_T_PPD_REV3 WHICH STATES: "WARNINGS: THE WIRE GUIDE SHOULD ALWAYS ADVANCE WITHOUT IMPEDANCE TO AVOID PERFORATION OF ANY SURROUNDING STRUCTURES. THE WIRE GUIDE SHOULD ALWAYS EXTEND BEYOND THE CATHETER TIP TO AVOID PERFORATION OF ANY SURROUNDING STRUCTURES. PRECAUTIONS: POSSIBLE ALLERGIC REACTIONS SHOULD BE CONSIDERED. THE PROCEDURE MAY REQUIRE TWO-DIMENSIONAL ECHOCARDIOGRAPHIC GUIDANCE OR FLUOROSCOPIC CONTROL TO CLOSELY MONITOR THE HEART DURING PLACEMENT INTO THE PERICARDIAL SPACE. A TFE-COATED WIRE GUIDE IS RECOMMENDED FOR A SMOOTHER CATHETER INTRODUCTION. INSTRUCTIONS FOR USE: PREPARE THE CHEST USING STANDARD ASEPTIC TECHNIQUE AND INFILTRATE THE INSERTION AREA WITH LOCAL ANESTHESIA. IF NEEDED MAKE A SMALL INCISION WITH A SCALPEL. DIRECT THE TIP OF THE NEEDLE TOWARDS THE DESIRED CATHETER PLACEMENT AND INSERT THE NEEDLE UNDER THE SKIN. IF PERICARDIUM IS THE TARGET . . . GENTLY ADVANCE THE NEEDLE INTO THE POSITIVE PRESSURE AREA. VERIFY PLACEMENT INTO THE PLEURAL OR PERICARDIAL SPACE BY ASPIRATION OF AIR OR FLUID INTO SYRINGE. REMOVE SYRINGE ONCE PLACEMENT IS VERIFIED. INTRODUCE THE WIRE GUIDE AND GENTLY ADVANCE IT INTO THE SELECTED CAVITY. NOTE: THE WIRE GUIDE SHOULD ADVANCE WITHOUT IMPEDANCE. REMOVE THE NEEDLE, LEAVING THE WIRE GUIDE IN PLACE, THEN DILATE WITH THE SUPPLIED DILATOR TO FACILITATE CATHETER INTRODUCTION. INTRODUCE THE CATHETER OVER THE WIRE GUIDE. NOTE: . . . ADVANCE THE CATHETER INTO POSITION. REMOVE THE WIRE GUIDE AND ATTACH THE MULTIPURPOSE ADAPTER TO THE CATHETER." THE COMPLETE IFU IS AVAILABLE AT: HTTPS://WWW.COOKMEDICAL.EU/DATA/IFU_PDF/C_T_PPD_REV3.PDF.

    Description of Event or Problem · 1

    THE SOURCE OF THE INCIDENT INFORMATION IS AN ARTICLE PUBLISHED IN THE IRISH TIMES ON 13 NOVEMBER 2017 (ROSEINGRAVE, LOUISE). MANUFACTURER BECAME AWARE OF THIS ARTICLE THROUGH A SALES DISCUSSION ON 12 DECEMBER 2017. ACCORDING TO THIS ARTICLE, A (B)(6)-OLD NEONATE ¿DIED AFTER A DOCTOR ATTEMPTING TO INSERT A LIFE-SAVING CHEST DRAIN PENETRATED HER HEART WITH PLASTIC TUBING¿. THE INCIDENT OCCURRED (B)(6) 2015. THE CITED ARTICLE SUMMARIZES THE FOLLOWING FACTS PRESENTED AT INQUEST: THE PROCEDURE WAS CARRIED OUT ON TWINS [BABY A AND BABY B] BORN PREMATURE AT (B)(6) WEEKS. BOTH NEWBORNS DEVELOPED RESPIRATORY DISTRESS AND WERE DIAGNOSED AS HAVING DEVELOPED A BUILD-UP OF AIR IN THE PLEURAL CAVITY. A DECISION WAS MADE TO INSERT A CHEST DRAIN TO RELIEVE PRESSURE ON THE INFANTS¿ HEARTS AND LUNGS. BABY A¿S ATTENDING NEONATAL PHYSICIAN INSERTED THE NEEDLE TWO TO THREE CENTIMETERS INTO BABY A¿S CHEST. THERE WERE ¿A FEW SPOTS OF BLOOD¿ INITIALLY WHICH HE SAID HE THOUGHT WAS A BURST BLOOD VESSEL. A NURSE ALERTED HIM TO THE PRESENCE OF BLOOD IN THE TUBING AS THE MONITORS ATTACHED TO BABY A BEGAN TO ALARM. BABY A DETERIORATED QUICKLY AND WAS TRANSFERRED TO ANOTHER FACILITY WHERE BABY A WAS PRONOUNCED DEAD AT 4:45PM ON (B)(6) 2015. THE CAUSE OF DEATH WAS A PERFORATED INJURY OF THE LEFT VENTRICLE OF THE HEART, FOLLOWING INSERTION OF CHEST DRAIN IN A PREMATURE BABY, ACCORDING TO PATHOLOGIST. THE PLASTIC TUBING ENTERED THE LEFT VENTRICLE OF THE BABY¿S HEART AT A DISTANCE OF 2.1CM FROM THE CHEST WALL. PER THE PATHOLOGIST, ¿IT WAS POSSIBLE THAT THE BABY¿S ORGANS COULD HAVE MOVED FOLLOWING THE RELEASE OF PRESSURE WITH THE INSERTION OF THE DRAIN AND NOTED THAT A PREMATURE BABY¿S INTERNAL ORGANS ARE ¿VERY SMALL¿. NEONATAL CONSULTANT AT THE HOSPITAL SAID THE TWINS WERE INITIALLY STABLE BUT THE BABY [BABY A] WAS NOT RESPONDING TO TREATMENTS ADMINISTERED TO STRENGTHEN HER BREATHING.¿ THERE WERE NO WRITTEN PROTOCOLS IN RELATION TO THE METHOD OF DRAIN INSERTION USED AT THE HOSPITAL AT THAT TIME. BABY B SURVIVED. THE MANUFACTURER CONTACTED THE FACILITY WHO SUGGESTED BUT COULD NOT CONFIRM THE DEVICE TO BE FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET (C-PPD-850-WCE-IMH). THE FACILITY DID STATE THEY RECEIVED THE IFU WITH THESE DEVICES. THE C-PPD-850-WCE-IMH IS USED FOR EVACUATION OF AIR FROM THE PERICARDIAL SAC OR TO DRAIN AIR OR FLUID FROM THE PLEURAL SPACE. 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. ADDITIONAL INFORMATION REGARDING THIS INCIDENT WAS REQUESTED ON 20DEC2017 AND OBTAINED ON 22DEC2017. THE CUSTOMER REPORTED THE PRODUCT INFORMATION THAT THEY BELIEVED CORRESPONDED TO THE COMPLAINT DEVICE, AND MEDICAL RECORDS WERE NOT IMMEDIATELY PROVIDED FOR EXAMINATION. THE CUSTOMER ALSO REPORTED THAT THEY DID NOT BELIEVE THE DEVICE WAS AT FAULT, AND INSTEAD INDICATED THAT IT WAS A COMPLICATION OF THE PROCEDURE ITSELF. THE PATIENT ALLEGEDLY EXPERIENCED A TENSION PNEUMOTHORAX IN A SEMI-CONTROLLED ENVIRONMENT LEADING UP TO THE EVENT. THE CUSTOMER ALSO VERIFIED THAT THE DEVICE HAD ENTERED THE PLEURAL SPACE BY ASPIRATING AIR FOR CONFIRMATION. NO ADDITIONAL IMAGING IS REPORTEDLY AVAILABLE. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28730 FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Death| R