MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-03 for SSD-201 manufactured by Medivators Inc..
[144102674]
A facility reported attempting to load the incorrect chemistry, rapicide pa high level disinfectant (hld), in their ssd-201 automated endoscope reprocessor (aer). Additionally, the scope technician loading the chemistry was exposed to rapicide pa hld on the right hand and left arm. Rapicide pa is not for use with the ssd-201 aer, therefore, the facility was not using their aer in accordance with the aer instructions for use. Thus, there is potential that endoscopes reprocessed in the aer were not appropriately high-level disinfected and, therefore, potential for patient cross-contamination. Rapicide pa part a and part b was reportedly being mixed by the user in the reservoir tank of the ssd-201 aer. Rapicide pa is a single shot chemistry that is dosed by the aer. The ssd-201 uses a reusable chemistry, thus, this is off-label use and user negligence of the instructions for use of both the chemistry and aer. Medivators technical services instructed the facility to remove the rapicide pa from the ssd-201. Medivators regulatory attempted to follow up with the facility for additional information with no success. The facility did not specify if any endoscopes were reprocessed using the incorrect hld. It is unknown if any medical attention was sought and if there were any lasting effects of the skin exposure. Additionally, it is unknown if the employee was wearing proper ppe (i. E. Gloves) when handling the hld as instructed per the product labeling. There have been no reports of patient harm. This complaint will continue to be monitored in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[144102675]
A facility reported attempting to load an incorrect chemistry, rapicide pa high level disinfectant (hld), in their ssd-201 automated endoscope reprocessor (aer). Additionally, the scope technician loading the chemistry was exposed to rapicide pa hld on the right hand and left arm. Rapicide pa is not for use with the ssd-201 aer, therefore, the facility was not using their aer in accordance with the aer instructions for use. Thus, there is potential that endoscopes reprocessed in the aer were not appropriately high-level disinfected and, therefore, potential for patient cross-contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00039 |
| MDR Report Key | 8579728 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2019-05-03 |
| 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 | HANNAH SHRADER |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635596863 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SSD-201 |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | FEB |
| Date Received | 2019-05-03 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-05-03 |