N
Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "CONTRAINDICATIONS USE OF AGENTOTM I.C. SILVER-COATED ENDOTRACHEAL TUBES IN PROCEDURES USING A LASER OR AN ELECTROSURGICAL ACTIVE ELECTRODE IN THE IMMEDIATE AREA OF THE DEVICE IS CONTRAINDICATED. CONTACT OF THE BEAM OR ELECTRODE WITH THE TRACHEAL TUBE, ESPECIALLY IN THE PRESENCE OF OXYGEN-ENRICHED OR NITROUS OXIDE CONTAINING MIXTURES COULD RESULT IN THE RAPID COMBUSTION OF THE TUBE WITH HARMFUL THERMAL EFFECTS AND WITH EMISSION OF CORROSIVE AND TOXIC COMBUSTION PRODUCTS INCLUDING HYDROCHLORIC ACID (HCL). IT HAS BEEN REPORTED BY HIRSHMAN AND SMITH THAT MIXTURES OF NITROUS OXIDE AND OXYGEN SUPPORT COMBUSTION ABOUT THE SAME AS PURE OXYGEN AND THAT IN ADDITION TO IGNITION BY DIRECT CONTACT WITH THE BEAM, THE INTERIOR OF THE TUBE CAN ALSO BE IGNITED BY CONTACT WITH FLAMING TISSUE IN CLOSE PROXIMITY TO THE TIP OF THE TRACHEAL TUBE (HIRSHMAN, C.A. AND SMITH, J.: INDIRECT IGNITION OF THE ENDOTRACHEAL TUBE DURING CARBON DIOXIDE LASER SURGERY. ARCH. OTOLARYNGOL. VOL. 106: 639-641, 1980). WARNINGS: THE USE OF LIDOCAINE TOPICAL AEROSOL HAS BEEN ASSOCIATED WITH THE FORMATION OF PINHOLES IN PVC (JAYASURIYA, K.D., AND WATSON, W.F.: P.V.C. CUFFS AND LIDOCAINE-BASE AEROSOL. BRIT. J. ANN. 53:1368, 1981). USE EXPERT CLINICAL JUDGMENT WHEN PRESCRIBING TREATMENT INVOLVING USE OF THIS SUBSTANCE. LIDOCAINE HYDROCHLORIDE SOLUTION DOES NOT HAVE THIS EFFECT; DO NOT OVER-INFLATE CUFF. ORDINARILY, THE CUFF PRESSURE SHOULD NOT EXCEED 25 CM H2O. CARROLL AND GRENVIK RECOMMEND MAINTAINING A SEAL PRESSURE AT OR BELOW 25 CM H2O (CARROLL, R.G., AND GRENVIK, A.: PROPER USE OF LARGE DIAMETER, LARGE RESIDUAL VOLUME CUFFS. CRIT. CARE. MED. VOL. 1, NO. 3: 153-154, 1973). OVERINFLATION CAN RESULT IN TRACHEAL DAMAGE, RUPTURE OF THE CUFF WITH SUBSEQUENT DEFLATION, OR IN CUFF DISTORTION WHICH MAY LEAD TO AIRWAY BLOCKAGE; DEFLATE CUFF PRIOR TO REPOSITIONING THE TUBE. MOVEMENT OF THE TUBE WITH THE CUFF INFLATED COULD RESULT IN PATIENT INJURY, REQUIRING POSSIBLE MEDICAL INTERVENTION OR DAMAGE TO THE CUFF, REQUIRING A TUBE CHANGE. WHEN COMPLETE EVACUATION OF THE AIR FROM THE CUFF IS ACCOMPLISHED, A DEFINITE VACUUM WILL BE NOTED IN THE SYRINGE AND THE TRACHEAL TUBE PILOT BALLOON IS COLLAPSED. VERIFY CORRECT PLACEMENT OF THE TUBE AFTER EACH REPOSITIONING. PRECAUTIONS THE SILVER ANTIMICROBIAL HYDROPHILIC COATING IS NOT INTENDED TO BE USED AS A THERAPEUTIC TREATMENT FOR INFECTIONS SUCH AS VAP; AS THESE DEVICES MAY HAVE BEEN SUBJECTED TO HANDLING, STORAGE CONDITIONS, OR PREPARATION WHICH COMPROMISED FUNCTIONAL INTEGRITY, EACH TUBE'S CUFF PILOT BALLOON AND VALVE SHOULD BE TESTED BY INFLATION PRIOR TO USE. IF DYSFUNCTION IS DETECTED IN ANY PART OF THE INFLATION SYSTEM, THE TUBE SHOULD NOT BE USED. INITIATING TREATMENT USING A TUBE ALREADY SHOWN TO HAVE A DYSFUNCTION IN THE INFLATION SYSTEM COULD UNNECESSARILY SUBJECT THE PATIENT TO THE UNTOWARD EFFECTS OF EXTUBATION, RE-INTUBATION, OR LOSS OF RESPIRATORY SUPPORT. FURTHERMORE, THE INTEGRITY OF THE INFLATION SYSTEM SHOULD BE MONITORED BOTH INITIALLY AND PERIODICALLY DURING THE INTUBATION PERIOD. UNCORRECTED FAILURE OF THE INFLATION SYSTEM COULD RESULT IN DEATH; VARIOUS BONY ANATOMICAL STRUCTURES (E.G., TEETH AND TURBINATES) WITHIN THE INTUBATION ROUTES OR ANY INTUBATION TOOLS WITH SHARP SURFACES PRESENT A THREAT TO MAINTAINING CUFF INTEGRITY. TAKE CARE TO AVOID DAMAGING THE THIN-WALLED CUFFS DURING INSERTION, WHICH WOULD CREATE THE NEED TO SUBJECT THE PATIENT TO THE TRAUMA OF EXTUBATION AND RE-INTUBATION. IF CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED; DIFFUSION OF NITROUS OXIDE MIXTURE, OXYGEN, OR AIR MAY EITHER INCREASE OR DECREASE CUFF VOLUME AND PRESSURE. INFLATING THE CUFF WITH A GAS MIXTURE IS RECOMMENDED AS A MEANS TO REDUCE THE EXTENT OF SUCH DIFFUSION; INFLATION OF THE CUFF BY "FEEL" ALONE OR BY USING A MEASURED AMOUNT OF AIR IS NOT RECOMMENDED SINCE RESISTANCE IS AN UNRELIABLE GUIDE DURING INFLATION. INTRACUFF PRESSURE SHOULD BE CLOSELY MONITORED WITH A PRESSURE MEASURING DEVICE; MINIMUM OCCLUDING VOLUME OR MINIMUM LEAK TECHNIQUES SHOULD BE USED IN CONJUNCTION WITH AN INTRACUFF PRESSURE MEASURING DEVICE IN SELECTING THE SEALING PRESSURE. CUFF PRESSURE SHOULD CONTINUE TO BE MONITORED THEREAFTER, AND ANY DEVIATION FROM THE SELECTED SEAL PRESSURE SHOULD BE INVESTIGATED AND CORRECTED IMMEDIATELY; SYRINGES, THREE-WAY STOPCOCKS OR OTHER DEVICES SHOULD NOT BE LEFT INSERTED IN THE INFLATION VALVE FOR EXTENDED PERIODS OF TIME. THE RESULTING STRESS COULD CRACK THE VALVE HOUSING AND ALLOW THE CUFF TO DEFLATE; WHEN A PATIENT'S POSITION OR THE TUBE PLACEMENT IS ALTERED AFTER INTUBATION, IT IS ESSENTIAL TO VERIFY THAT THE TUBE POSITION REMAINS CORRECT. ANY TUBE DISPLACEMENT SHOULD BE CORRECTED IMMEDIATELY; EXPOSURE TO ELEVATED TEMPERATURES (I.E., GREATER THAN AMBIENT TEMPERATURE) AND ULTRAVIOLET LIGHT SHOULD...
D
Patient 1
A REPORT WAS RECEIVED ON 09/25/2015 ALLEGING A (B)(6), FEMALE PATIENT DEATH OCCURRED AT (B)(6) MEDICAL CENTER WHILE A PATIENT WAS USING AN ENDOTRACHEAL TUBE. INFORMATION GIVEN WAS THAT THE PATIENT WAS ON A VENTILATOR FOR A BRONCHOSCOPY PROCEDURE. IT WAS REPORTED THAT AFTER AN HOUR OF INTUBATION AND BEING PLACED ON HEATED, HUMIDIFIED CIRCUIT, THE PURPLE 15MM ADAPTER DID NOT REMAIN SEATED IN THE ENDOTRACHEAL TUBING. THE FACILITY REPRESENTATIVE CONFIRMED THAT THE PATIENT DIED ON (B)(6) 2015 DUE TO CARDIAC ARREST. THE FACILITY INDICATED THAT THE ENDOTRACHEAL TUBE DEVICE WAS NOT RELATED TO THE PATIENT'S DEATH.
N
Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "CONTRAINDICATIONS USE OF AGENTO TM I.C. SILVER-COATED ENDOTRACHEAL TUBES IN PROCEDURES USING A LASER OR AN ELECTROSURGICAL ACTIVE ELECTRODE IN THE IMMEDIATE AREA OF THE DEVICE IS CONTRAINDICATED. CONTACT OF THE BEAM OR ELECTRODE WITH THE TRACHEAL TUBE, ESPECIALLY IN THE PRESENCE OF OXYGEN-ENRICHED OR NITROUS OXIDE CONTAINING MIXTURES COULD RESULT IN THE RAPID COMBUSTION OF THE TUBE WITH HARMFUL THERMAL EFFECTS AND WITH EMISSION OF CORROSIVE AND TOXIC COMBUSTION PRODUCTS INCLUDING HYDROCHLORIC ACID (HCL). IT HAS BEEN REPORTED BY (B)(6) THAT MIXTURES OF NITROUS OXIDE AND OXYGEN SUPPORT COMBUSTION ABOUT THE SAME AS PURE OXYGEN AND THAT IN ADDITION TO IGNITION BY DIRECT CONTACT WITH THE BEAM, THE INTERIOR OF THE TUBE CAN ALSO BE IGNITED BY CONTACT WITH FLAMING TISSUE IN CLOSE PROXIMITY TO THE TIP OF THE TRACHEAL TUBE (HIRSHMAN, C.A. AND SMITH, J.: INDIRECT IGNITION OF THE ENDOTRACHEAL TUBE DURING CARBON DIOXIDE LASER SURGERY. ARCH. OTOLARYNGOL. VOL. 106: 639-641, 1980). WARNINGS: THE USE OF LIDOCAINE TOPICAL AEROSOL HAS BEEN ASSOCIATED WITH THE FORMATION OF PINHOLES IN PVC (JAYASURIYA, K.D., AND WATSON, W.F.: P.V.C. CUFFS AND LIDOCAINE-BASE AEROSOL. BRIT. J. ANN. 53:1368, 1981). USE EXPERT CLINICAL JUDGMENT WHEN PRESCRIBING TREATMENT INVOLVING USE OF THIS SUBSTANCE. LIDOCAINE HYDROCHLORIDE SOLUTION DOES NOT HAVE THIS EFFECT. DO NOT OVER-INFLATE CUFF. ORDINARILY, THE CUFF PRESSURE SHOULD NOT EXCEED 25 CM H2O. (B)(6) RECOMMEND MAINTAINING A SEAL PRESSURE AT OR BELOW 25 CM H2O (CARROLL, R.G., AND GRENVIK, A.: PROPER USE OF LARGE DIAMETER, LARGE RESIDUAL VOLUME CUFFS. CRIT. CARE. MED. VOL. 1, NO. 3: 153-154, 1973). OVERINFLATION CAN RESULT IN TRACHEAL DAMAGE, RUPTURE OF THE CUFF WITH SUBSEQUENT DEFLATION, OR IN CUFF DISTORTION WHICH MAY LEAD TO AIRWAY BLOCKAGE. DEFLATE CUFF PRIOR TO REPOSITIONING THE TUBE. MOVEMENT OF THE TUBE WITH THE CUFF INFLATED COULD RESULT IN PATIENT INJURY, REQUIRING POSSIBLE MEDICAL INTERVENTION OR DAMAGE TO THE CUFF, REQUIRING A TUBE CHANGE. WHEN COMPLETE EVACUATION OF THE AIR FROM THE CUFF IS ACCOMPLISHED, A DEFINITE VACUUM WILL BE NOTED IN THE SYRINGE AND THE TRACHEAL TUBE PILOT BALLOON IS COLLAPSED. VERIFY CORRECT PLACEMENT OF THE TUBE AFTER EACH REPOSITIONING. PRECAUTIONS THE SILVER ANTIMICROBIAL HYDROPHILIC COATING IS NOT INTENDED TO BE USED AS A THERAPEUTIC TREATMENT FOR INFECTIONS SUCH AS VAP. AS THESE DEVICES MAY HAVE BEEN SUBJECTED TO HANDLING, STORAGE CONDITIONS, OR PREPARATION WHICH COMPROMISED FUNCTIONAL INTEGRITY, EACH TUBE'S CUFF PILOT BALLOON AND VALVE SHOULD BE TESTED BY INFLATION PRIOR TO USE. IF DYSFUNCTION IS DETECTED IN ANY PART OF THE INFLATION SYSTEM, THE TUBE SHOULD NOT BE USED. INITIATING TREATMENT USING A TUBE ALREADY SHOWN TO HAVE A DYSFUNCTION IN THE INFLATION SYSTEM COULD UNNECESSARILY SUBJECT THE PATIENT TO THE UNTOWARD EFFECTS OF EXTUBATION, RE-INTUBATION, OR LOSS OF RESPIRATORY SUPPORT. FURTHERMORE, THE INTEGRITY OF THE INFLATION SYSTEM SHOULD BE MONITORED BOTH INITIALLY AND PERIODICALLY DURING THE INTUBATION PERIOD. UNCORRECTED FAILURE OF THE INFLATION SYSTEM COULD RESULT IN DEATH. VARIOUS BONY ANATOMICAL STRUCTURES (E.G., TEETH AND TURBINATES) WITHIN THE INTUBATION ROUTES OR ANY INTUBATION TOOLS WITH SHARP SURFACES PRESENT A THREAT TO MAINTAINING CUFF INTEGRITY. TAKE CARE TO AVOID DAMAGING THE THIN-WALLED CUFFS DURING INSERTION, WHICH WOULD CREATE THE NEED TO SUBJECT THE PATIENT TO THE TRAUMA OF EXTUBATION AND RE-INTUBATION. IF CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED. DIFFUSION OF NITROUS OXIDE MIXTURE, OXYGEN, OR AIR MAY EITHER INCREASE OR DECREASE CUFF VOLUME AND PRESSURE. INFLATING THE CUFF WITH A GAS MIXTURE IS RECOMMENDED AS A MEANS TO REDUCE THE EXTENT OF SUCH DIFFUSION. INFLATION OF THE CUFF BY "FEEL" ALONE OR BY USING A MEASURED AMOUNT OF AIR IS NOT RECOMMENDED SINCE RESISTANCE IS AN UNRELIABLE GUIDE DURING INFLATION. INTRACUFF PRESSURE SHOULD BE CLOSELY MONITORED WITH A PRESSURE MEASURING DEVICE. MINIMUM OCCLUDING VOLUME OR MINIMUM LEAK TECHNIQUES SHOULD BE USED IN CONJUNCTION WITH AN INTRACUFF PRESSURE MEASURING DEVICE IN SELECTING THE SEALING PRESSURE. CUFF PRESSURE SHOULD CONTINUE TO BE MONITORED THEREAFTER, AND ANY DEVIATION FROM THE SELECTED SEAL PRESSURE SHOULD BE INVESTIGATED AND CORRECTED IMMEDIATELY. SYRINGES, THREE-WAY STOPCOCKS OR OTHER DEVICES SHOULD NOT BE LEFT INSERTED IN THE INFLATION VALVE FOR EXTENDED PERIODS OF TIME. THE RESULTING STRESS COULD CRACK THE VALVE HOUSING AND ALLOW THE CUFF TO DEFLATE. WHEN A PATIENT'S POSITION OR THE TUBE PLACEMENT IS ALTERED AFTER INTUBATION, IT IS ESSENTIAL TO VERIFY THAT THE TUBE POSITION REMAINS CORRECT. ANY TUBE DISPLACEMENT SHOULD BE CORRECTED IMMEDIATELY. EXPOSURE TO ELEVATED TEMPERATURES (I.E., GREATER THAN AMBIENT TEMPERATURE) AND ULTRAVIOLET LIGHT SHOULD BE AVOIDED DURING STORA...
D
Patient 1
A REPORT WAS RECEIVED ON (B)(6) 2015 ALLEGING A (B)(6) OLD, FEMALE PATIENT DEATH OCCURRED AT (B)(6) CENTER WHILE A PATIENT WAS USING AN ENDOTRACHEAL TUBE. INFORMATION GIVEN WAS THAT THE PATIENT WAS ON A VENTILATOR FOR A BRONCHOSCOPY PROCEDURE. IT WAS REPORTED THAT AFTER AN HOUR OF INTUBATION AND BEING PLACED ON HEATED, HUMIDIFIED CIRCUIT, THE PURPLE 15MM ADAPTER DID NOT REMAIN SEATED IN THE ENDOTRACHEAL TUBING. THE FACILITY REPRESENTATIVE CONFIRMED THAT THE PATIENT DIED ON (B)(6) 2015 DUE TO CARDIAC ARREST. THE FACILITY INDICATED THAT THE ENDOTRACHEAL TUBE DEVICE WAS NOT RELATED TO THE PATIENT'SDEATH. THE PATIENTREPORTED DEATH WAS AN INCIDENTAL ELEMENT OF THE PATIENTMEDICAL HISTORY AND WAS UNRELATED TO THE REASON FOR THE COMPLAINT. THERE WAS NO INDICATION, REPORT OR ALLEGATION THAT THE DEVICE MALFUNCTION WAS RELATED TO THE PATIENT'S DEATH.