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.
[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
| Report Number | 2084725-2016-00412 |
| MDR Report Key | 5806974 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2016-07-25 |
| Date Added to Maude | 2016-07-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAQUIN KURZ |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIDEX ACTIVATED DIALDEHYDE SOLUTION |
| Generic Name | BIOCIDES SOLUTIONS (LRJ) |
| Product Code | LRJ |
| Date Received | 2016-07-19 |
| Model Number | NA |
| Catalog Number | SCX145 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-07-19 |