BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 4337252 · Received December 10, 2014

    Report

    Report Number
    2648988-2014-00071
    Event Type
    Death
    Date Received
    December 10, 2014
    Date of Event
    September 28, 2014
    Report Date
    November 21, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AS PER MEDWATCH - MFR REPORT # (B)(4): (B)(6) MALE PATIENT WITH A HISTORY OF ONGOING PULMONARY ARTERIAL HYPERTENSION AND ONGOING HAEMOFILTRATION - USED TO TREAT ACUTE RENAL FAILURE, DIED ON (B)(6) 2014, FOLLOWING A BRADYCARDIAC ARREST WITH AN EPISODE OF GAGGING/VOMITING, IN THE ICU. IT IS REPORTED THE PATIENT DIED FROM THE INFECTION, SEPSIS, RENAL FAILURE AND BRADYCARDIAC ARREST. THE PATIENT HAD BEEN UNDERGOING TREATMENT FOR AN OCCURRENCE OF ITCHING, BLISTERING AT PICC LINE SITE AND DRAINAGE FROM CENTRAL LINE SITE 8 WEEKS PRIOR TO THE EVENTS PRECEDING HIS DEATH. THIS WAS IN ADDITION TO TREATMENT FOR HIS ONGOING ILLNESS SEQUELAE, INCLUDING THE RECALCITRANT PULMONARY ARTERIAL HYPERTENSION. IT IS REPORTED THAT FOLLOW UP INFORMATION RECEIVED ON (B)(4) 2014 INDICATES CO-SUSPECT PRODUCTS RELATED TO THE CATHETER SITE IRRITATION ARE CHLORAPREP AND BIOPATCH. "THE PATIENT HAD ISSUES WITH IRRITATION/RASH UNDER THE DRESSING. A NURSE SAW THE PATIENT ON (B)(6) 2014 AND THE PATIENT SAW THE DOCTOR AND HAD BLOOD DRAWS PERFORMED AND A SWAB OF THE SITE (RESULTS WERE NOT PROVIDED). THE DOCTOR IS REQUESTING THE PATIENT TO STOP USING CHLORAPREP AND THE BIOPATCH AND CLEAN WITH ALCOHOL ONLY. AT THE TIME OF REPORTING, THE OUTCOME OF THE RASH AND IRRITATION AT THE CATHETER SITE WAS UNKNOWN." FOLLOW UP INFORMATION RECEIVED ON (B)(4) 2014 INDICATES, "THE PATIENT STATED THAT ON MONDAY ((B)(6) 2014), THE PATIENT WENT TO THE HOSPITAL WITH 103 DEGREE TEMPERATURE AND WAS ADMITTED TO THE ICU (INTENSIVE CARE UNIT). 'CL (CENTRAL LINE) PULLED-PIC (PERIPHERALLY INSERTED CATHETER) PUT IN.' THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS FOR INFECTION. 'RETAINING FLUID' WAS ALSO REPORTED...... THE PATIENT WAS CURRENTLY IN THE MICU (MEDICAL INTENSIVE CARE UNIT) ROOM. THERE WERE NO DISCHARGE PLANS AT THE TIME OF REPORTING. NO OTHER INFORMATION WAS PROVIDED." FOLLOW UP INFORMATION RECEIVED FROM A PHYSICIAN ON 16OCT 2014 INDICATES, "...THE ADDITIONAL EVENTS OF SEPSIS, INTENSIVE CARE, DEVICE RELATED INFECTION, RENAL FAILURE ACUTE, CARDIAC ARREST, BRADYCARDIA, RETCHING AND VOMITING WERE REPORTED. THE PHYSICIAN STATED 'THE RASH IMPROVED BUT NEVER RESOLVED ENTIRELY. HE WAS ADMITTED TO THE HOSPITAL (B)(6) 2014 WITH SEPSIS, AND WAS ULTIMATELY FOUND TO HAVE AN INFECTION OF HIS CENTRAL LINE AS EVIDENCED BY POSITIVE LINE TIP CULTURES. HE WAS IMPROVING WITH ANTIBIOTICS BUT THEN DEVELOPED ACUTE RENAL FAILURE, WAS STARTED ON CONTINUOUS VENA-VENOUS HEMOFILTRATION, AND ULTIMATELY HAD A BRADYCARDIAC ARREST... ' THE PHYSICIAN NOTED THAT THE SYMPTOMS IMPROVED (ONLY SPECIFIED THAT DEVICE RELATED INFECTION IMPROVED, HOWEVER ALSO REPORTED THAT THE EVENT WAS FATAL. THE EVENTS OF SEPSIS, RENAL FAILURE ACUTE, CARDIAC ARREST, BRADYCARDIA AND DEVICE RELATED INFECTION WERE FATAL. THE OUTCOME OF THE EVENTS OF INTENSIVE CARE, RETCHING AND VOMITING WAS UNKNOWN. THE PHYSICIAN REPORTED THAT THE EVENTS COULD HAVE BEEN RELATED TO PULMONARY HYPERTENSION AND THE PRESENCE OF CENTRAL LINE FOR FLOLAN ADMINISTRATION. THE PHYSICIAN REPORTED THAT IT WAS POSSIBLE THAT THE EVENTS (UNSPECIFIED) WERE POSSIBLY RELATED TO GSK PRODUCTS (FIOLAN AND POSSIBLY AMBRISENTAN AS THESE MEDICATIONS WERE BOTH GSK PRODUCTS)." IT WAS REPORTED AS PER FOLLOW UP MEDWATCH - MFR REPORT # (B)(4): CONCURRENT MEDICAL CONDITIONS INCLUDED PRIMARY PULMONARY HYPERTENSION. DURING ONGOING INTRAVENOUS TREATMENT FOR PRIMARY PULMONARY HYPERTENSION, THE PATIENT EXPERIENCED CENTRAL LINE CATHETER SITE DRAINAGE AND ITCHING/BLISTERING AT THE PICC LINE SITE ON (B)(6) 2014. "THE NURSE REPORTED THAT THE PATIENT HAD DRAINAGE A THE SITE WITH ITCHING AND LITTLE WATER BLISTERS AROUND THE SITE DIRECTLY UNDER THE COMPLETE DRESSING. PATIENT QUESTIONED IF IT WOULD BE ALRIGHT IF HE LEFT THE GAUZE ON LOOSELY UNTIL HEALING OCCURRED. THE PATIENT THOUGHT HE MIGHT BE HAVING A REACTION TO THE DRESSING... " FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN, INCLUDING AN AUTOPSY REPORT, ON 4NOV2014. THE PATIENT DIED ON (B)(6) 2014, NOT (B)(6) 2014 AS REPORTED PREVIOUSLY. "PER THE AUTOPSY REPORT THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF PULMONARY ARTERIAL HYPERTENSION, ON TRIPLE THERAPY AT HOME (REVATIO, FLOLAN, LETAIRIS), AS WELL AS OBSTRUCTIVE SLEEP APNEA; GASTROESOPHAGEAL REFLUX DISEASE, AND ASTHMA... HE PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AFTER SYNCOPAL EPISODE ON (B)(6) 2014. HE WAS FOUND TO BE HYPOTENSIVE AND FEVERISH (WHITE BLOOD CELLS 11.3 X 10'9/L, .....)... IT WAS UNCLEAR WHETHER HIS SEPSIS WAS DUE TO AN ABDOMINAL SOURCE OR POSSIBLY AN INDWELLING CATHETER FOR PULMONARY HYPERTENSIVE MEDICATION. AN ABDOMINAL ULTRASOUND WAS UNREVEALING.... THE TUNNELED LINE WAS REMOVED THE DAY AFTER ADMISSION, ALTHOUGH THERE WAS NO ERYTHEMA OR TENDERNESS; TIP CULTURE GREW STAPHYLOCOCCUS AUREUS, HOWEVER, BLOOD CULTURES WERE NEGATIVE.... AFTER LINE REMOVAL, HE CONTINUED TO HAVE OCCASIONAL FEVERS...HE WAS TREATED WITH BROAD SPECTRUM ANTIBIOTICS, CONTINUOUS VENO-VENO HEMOFILTRATION FOR KIDNEY FAILURE, AND SUPPORTIVE MEASURES..." THE EVENTS IMMEDIATELY PRECEDING THE PATIENT DEATH, INCLUDING RESUSCITATIVE MEASURES, ARE DESCRIBED. "CLINICAL SYMPTOMS EXPERIENCED IN LIFE RELATED TO THE HISTORY WERE SHORTNESS OF BREATH AND HYPOXIA REQUIRING OXYGEN. AUTOPSY FINDINGS THAT CORROBORATED WITH PULMONARY HYPERTENSION INCLUDED NUMEROUS CLASSIC PLEXIFORM LESIONS AND MEDIAL HYPERTROPHY INVOLVING THE SMALL BLOOD VESSELS OF THE LUNGS, AS WELL AS SIGNIFICANT ATHEROSCLEROSIS IN LARGER PULMONARY VESSELS." ADDITIONAL AUTOPSY FINDINGS ARE DESCRIBED. "A CAUSE FOR HIS FEVERISH PRESENTATION ON FINAL ADMISSION WAS NOT UNCOVERED CLINICALLY, DESPITE AN EXTENSIVE INFECTIOUS WORKUP, EXCHANGE OF HIS INDWELLING CATHETER, AND PLACEMENT ON BROAD-SPECTRUM ANTIBIOTICS. "BASED ON THE AUTOPSY AND CLINICAL PATHOLOGICAL CORRELATION, THIS PATIENT'S UNDERLYING CAUSE OF DEATH WAS DUE TO SEVERE PULMONARY ARTERIAL HYPERTENSION....THE PHYSICIAN INDICATED THE EVENTS COULD HAVE BEEN ASSOCIATED WITH THE CONCURRENT ILLNESS OF PULMONARY ARTERIAL HYPERTENSION. THE PHYSICIAN DID NOT ADDRESS CAUSALITY FOR THE NEWLY ADDED EVENTS. THE PHYSICIAN INDICATED THAT THE DEATH WAS UNLIKELY RELATED TO CHLORAPREP AND BIOPATCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797320 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death CHLORAPREP