BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 7246279 · Received February 6, 2018

    Report

    Report Number
    1820334-2018-00162
    Event Type
    Death
    Date Received
    February 6, 2018
    Date of Event
    December 31, 2017
    Report Date
    April 20, 2018
    Manufacturer
    COOK INC
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA , AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE LOT NUMBER FOR THE COMPLAINT DEVICE IS NOT KNOWN. THEREFORE A SEARCH FOR LOT RELATED COMPLAINTS CANNOT BE PERFORMED. LIKEWISE, THE DHR CANNOT BE REVIEWED FOR LOT RELATED NON-CONFORMANCES. HOWEVER, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION BY THE END USER. IT IS FEASIBLE THAT THE USER FACILITY HAS ACCESS TO STOPCOCKS SUPPLIED BY MULTIPLE MANUFACTURERS. ALTHOUGH, THE 3 -WAY STOPCOCK (PTWSC-2FLL-MLL-R-LP) IS SUPPLIED WITH THE C-PPD-850-WCE-IMH SET, THERE IS NO REQUIREMENT THAT THE END USER USE THE SUPPLIED STOPCOCK. BECAUSE STOPCOCKS ARE NOT ALWAYS SUPPLIED WITH INSTRUCTIONS FOR USE AND ARE CONSIDERED GENERAL PURPOSE DEVICE, CLINICIANS ARE ENCOURAGED TO BECOME FAMILIAR WITH THE ACTUAL FUNCTION OF THE DEVICE BEFORE USING IT IN A CLINICAL SETTING. THIS COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AND WILL BE TRENDED AS USE ERROR. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. A CUSTOMER RESPONSE LETTER HAS BEEN DRAFTED TO PROVIDE CUSTOMER FEEDBACK FOR CUSTOMER CONCERNS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. CURRENTLY, A DOCUMENT BASED INVESTIGATION EVALUATION IS PERFORMED. TO DATE, THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. INSTRUCTION FOR USE (IFU); FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET SATES THAT THE SET IS INTENDED FOR EVACUATION OF AIR FROM THE PERICARDIAL SAC OR DRAINAGE OF AIR OR FLUID FROM THE PLEURAL SPACE. THIS REPORT INCLUDES RELEVANT INFORMATION KNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PMA / 510K STATUS: EXEMPT. (B)(4). PER CLINICAL REVIEW: THE MOST LIKELY CAUSES OF THE PATIENT DEATH ARE USE ERROR RELATED OR DISEASE PROGRESSION RELATED. INSTRUCTION FOR USE (IFU); FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET SATES THAT THE SET IS INTENDED FOR EVACUATION OF AIR FROM THE PERICARDIAL SAC OR DRAINAGE OF AIR OR FLUID FROM THE PLEURAL SPACE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE..

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE FOLLOWING INFORMATION WAS RECEIVED IN RESPONSE TO ADDITIONAL QUESTIONS REQUESTED. A SECOND (B)(6) VIA IVP CS WITH COMPLICATIONS. A CESAREAN SECTION WAS PERFORMED AT (B)(6). A PREMATURE MALE WEIGHING (B)(6). THE PATIENT WAS ARTIFICIALLY VENTILATED AND MORPHINE WAS ADMINISTERED FOR THE PLACEMENT OF THE THORACIC DRAIN PLACEMENT INDICATED FOR A LEFT SIDED TENSION PNEUMOTHORAX. AFTER AN EASY PLACEMENT OF THE DRAIN, THE 3-WAY STOPCOCK WAS PLACED AND CONNECTED. DURING PLACEMENT, IT BECAME CLEAR THAT THE OPERATOR WAS NOT FAMILIAR WITH THE DEVICE. SO IT WAS USED INCORRECTLY, AND AIR WAS BROUGHT INTO THE THORAX. FOLLOWING THIS, THE STOPCOCK WAS REMOVED, AND AIR WAS REMOVED WITH A SYRINGE. A CLASSIC STOPCOCK WAS THEN ULTIMATELY CONNECTED TO THE SYSTEM. AN AUTOPSY WAS NOT PERFORMED AS THE PATIENT DID NOT EXPIRE IMMEDIATELY FOLLOWING THE ISSUE WITH THE PRODUCT. THE CAUSE OF DEATH WAS DETERMINED TO BE SEPTIC SHOCK, THEREFORE NO AUTOPSY WAS REQUESTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY CALLED TO INQUIRE IF THE THREE-WAY STOPCOCK PORTION OF THE DEVICE HAD BEEN CHANGED. THE CUSTOMER REPORTED THAT, DURING THE USE OF THE FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET IN A PEDIATRIC PATIENT, 200 ML OF AIR WAS INSERTED INTO THE PATIENT'S LUNGS. THE PATIENT WAS COVERED DURING THE PROCEDURE. THE PATIENT EXPIRED A FEW DAYS LATER. THE CUSTOMER DID CONFIRM THAT THE PATIENT'S CONDITION WAS ALREADY POOR, AND THE PATIENT DID NOT EXPIRE UNTIL A FEW DAYS FOLLOWING THE INCIDENT. THE INCIDENT REPORTEDLY OCCURRED SOMETIME IN 2017 (EXACT DATE NOT REPORTED). THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION. ADDITIONAL INFORMATION RECEIVED (B)(6) 2017: THE (B)(6) INDICATED THE DEATH OCCURRED TEN DAYS AFTER THE CHEST DRAIN PROCEDURE AND FEELS THERE IS NOT A DIRECT LINK WITH THE DEATH AND IMPROPER USE. HE COMMENTED THIS DEVICE IS NOT FREQUENTLY USED IN THE NEONATOLOGY DEPARTMENT (ONLY A FEW UNITS PER YEAR). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT AS OF THIS DATE, HAS NOT BEEN RECEIVED AS THE CUSTOMER IS AWAITING INTERNAL PERMISSION TO RELEASE INFORMATION. ADDITIONAL QUESTIONS REQUESTED INCLUDE: 1. PLEASE DESCRIBE ANY SPECIFIC PRE-EXISTING CONDITIONS, TO INCLUDE ANY LABOR AND DELIVERY COMPLICATIONS? 2. PLEASE PROVIDE PATIENT DEMOGRAPHICS: GESTATIONAL AGE OF INFANT, WEEKS GRAVIDA, SEX, WEIGHT, ETC. 3. WHAT MEDICATIONS AND/OR OTHER DEVICES WERE USED DURING PROCEDURE? 4. WHAT PROCEDURE WAS BEING PERFORMED WHEN THE ISSUE OCCURRED AND IN WHAT PART OF THE BODY? 5. WHY WAS THE PROCEDURE BEING PERFORMED? 6. DESCRIBE IN DETAIL THE ISSUE WITH THE 3-WAY STOPCOCK. 7. WHAT ACTIONS WERE TAKEN IMMEDIATELY FOLLOWING THE ISSUE? 8. WAS AN AUTOPSY PERFORMED? IF SO, IS AN AUTOPSY REPORT AVAILABLE FOR RELEASE? 9. IF NO AUTOPSY WAS PERFORMED, WHAT WAS PHYSICIAN STATED CAUSE OF DEATH?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88255 FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death