MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-10 for CER-2 OPTIMA manufactured by Medivators, Inc..
[89124825]
The facility reportedly observed that the metricide opa plus high level disinfectant used in their cer-2 optima automated endoscope reprocessor hld reservoir was cloudy in appearance. The facility confirmed that the opa solution was not expired and the minimum required concentration (mrc) passed for the reprocessing cycle. The initial reporter thought someone may have accidentally topped off the disinfectant reservoir with metrizyme detergent, which they use as part of their pre-cleaning step prior to high-level disinfecting scopes. Therefore, it is unknown if scopes were properly high-level disinfected. It is also unknown if scopes were used on patients, thus potential risk of patient adverse effects from improper hld of scopes. Medivators technical services advised the customer to dump the disinfectant from the reservoir, rinse thoroughly with water, then refill with the opa solution and test the mrc using the solution test strips. The customer followed these directions and confirmed that the mrc passed. To date, there have been no reports of patient harm. Medivators will continue monitoring this complaint in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[89124826]
A facility reported noticing the metricide opa plus high level disinfectant used in their cer 2 optima automated endoscope reprocessor hld reservoir was cloudy in appearance. It was suspected that someone accidentally topped off the disinfectant reservoir with metrizyme detergent. There is potential for patient adverse effects such as cross contamination if scopes are not properly high level disinfected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2017-00044 |
| MDR Report Key | 6934997 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2012-07-18 |
| Date Added to Maude | 2017-10-10 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MEDIVATORS, INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CER-2 OPTIMA |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2017-10-10 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS, INC. |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-10 |