CIDEX ACTIVATED DIALDEHYDE SOLUTION SCX145

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-19 for CIDEX ACTIVATED DIALDEHYDE SOLUTION SCX145 manufactured by Advanced Sterilization Products.

Event Text Entries

[49944179] Ni
Patient Sequence No: 1, Text Type: N, H10


[49944180] An international affiliate reported three patients exhibited fever, five hours after having a bronchoscopy procedure, and the bronchoscope was reported to have been cleaned with cidezyme enzymatic detergent and high level disinfected with cidex activated solution. This report is for patient #2 who had the procedure done on (b)(6) 2016. The affiliate reported the patient was admitted in the hospital when the procedure was done, and the event was exhibited. Advanced sterilization products (asp) has requested detailed information regarding this event; however asp has not received anything further to date. At the time the reporting determination was made, a decision was made to file a fda medwatch report based on the limited information in the complaint, and due to the fact that the customer reported using cidezyme enzymatic detergent and cidex activated solution for cleaning and disinfection. However, it is unknown whether or not the symptoms reported were related. Asp will continue to gather additional information. Please reference patient #1: 1-(b)(4) and 1-(b)(4), patient #2: 1-(b)(4) and 1-(b)(4), patient #3: 1-(b)(4) and 1-(b)(4). This is two of six reports being submitted for this event. Please reference manufacturer report numbers: 2084725-2016-00411, 2084725-2016-00412, 2084725-2016-00413, 2084725-2016-00414, 2084725-2016-00415, and 2084725-2016-00416.
Patient Sequence No: 1, Text Type: D, B5


[51483661] After further clarification, this patient was not admitted to the hospital related to the symptoms reported in this event. Instead, patient #2 was already admitted prior to the bronchoscopy with this admitting diagnosis: small cell lung cancer. The updated report from the customer noted patient #2 had one febrile episode which developed 4-6 hours after the bronchoscopy. The patient was given an anti-pyretic, and the fever resolved and did not recur. No chest x-ray was done. The customer reported the bronchoscopes used in the procedures were cultured. One of the scopes tested positive for staphylococcus; however it is unknown if this scope was used on patient #2. The hospital did not perform cultures on patient #2 related to this event; in addition, it was reported the patient? S fever had resolved. The customer reported after their internal investigation, they did not attribute this event to asp products. They did however implement the following interventions, and reported they have had no similar events after these interventions were done. Adherence to correct cleaning methodology. Strict use of personal protective equipment. Execute the device manufacturer? S guidelines on proper use of cleaning agents. Perform random cultures. Removed old scopes and starting using new ones. At the time the reporting determination was made, a decision was made to file a fda medwatch report based on the limited information, and due to the fact that the customer reported using asp products. However, after further investigation and based on new information received on 07/25/16, this complaint is deemed not reportable. There is no report of death or serious injury attributed to an asp product, or that an asp product was or may have been a factor in a death or serious injury.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2084725-2016-00412
MDR Report Key5806974
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-07-19
Date of Report2016-06-22
Date of Event2016-06-10
Date Mfgr Received2016-07-25
Date Added to Maude2016-07-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOAQUIN KURZ
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9497893837
Manufacturer G1ADVANCED STERILIZATION PRODUCTS
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCIDEX ACTIVATED DIALDEHYDE SOLUTION
Generic NameBIOCIDES SOLUTIONS (LRJ)
Product CodeLRJ
Date Received2016-07-19
Model NumberNA
Catalog NumberSCX145
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerADVANCED STERILIZATION PRODUCTS
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2016-07-19

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