MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-09-22 for CIDEX OPA SOLUTION 20390 manufactured by Advanced Sterilization Products.
[87881252]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87881253]
A customer reported a patient had a? Black line? On his face after a procedure using a transesophageal echocardiography (tee) probe which had been cleaned and high-level disinfected with cidex opa solution. The tee probe laid on the patient? S face, and there was no barrier or drape between the probe and the patient? S skin. It was reported the patient was alert, oriented and talking immediately after the procedure and was? Fine?. No medical attention was necessary and the black mark was gone the following day. Regarding the rinsing process, it was reported this was an isolated event, however, a new technician did not properly rinse the tee probe and did not follow cidex opa instructions for use (ifu). Instead, the technician rinsed the probe under the faucet with running water for approximately 5 minutes, while scrubbing at the same time, then dried it. The ifu states the instruments should be submerged completely into a clean, large water container for a minimum of one minute. This should be repeated twice for a total of three rinses. Failure to rinse devices per the ifu may result in patient side effects, including serious allergic reaction to residues or discoloration of tissues. The customer was advised to follow the ifu from now on. Since this event occurred, the facility has now implemented device cleaning and rinsing per cidex opa ifu. There is no harm and no serious injury reported in this complaint, and the temporary skin stain resolved the next day without medical intervention; however, as a matter of policy, advanced sterilization products (asp) has decided to report cases of improperly rinsed instruments after using cidex? Opa solution since it could result in serious patient side effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2017-00581 |
| MDR Report Key | 6887404 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-11-03 |
| Date Added to Maude | 2017-09-22 |
| 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 | MR. JOAQUIN KURZ |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| 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 OPA SOLUTION |
| Generic Name | BIOCIDES SOLUTION |
| Product Code | JOJ |
| Date Received | 2017-09-22 |
| Catalog Number | 20390 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-09-22 |