MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-09 for RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS ML02-0118 manufactured by Medivators.
[107730210]
Medivators field service engineer reported, while on site servicing the facility's advantage plus automated endoscope reprocessor, the facility had been using expired test strips to check the minimum required concentration (mrc) of rapicide pa high level disinfectant used in the aer. There is potential that hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected. Medivators fse informed the operators and team leader that the test strips were expired and the facility were going to order new test strips immediately. Rapicide pa test strips instructions for use warns users to not use the strips after the expiration date. There have been no reports of patient harm. This complaint will continue being monitored in medivators complaint handling system. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107730211]
Medivators field service engineer reported, while on site servicing the facility's advantage plus automated endoscope reprocessor, the facility had been using expired test strips to check the minimum required concentration (mrc) of rapicide pa high level disinfectant used in the aer. There is potential that hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2018-00037 |
| MDR Report Key | 7498577 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-09 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-04-11 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2018-05-09 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS |
| Generic Name | CHEMICAL INDICATOR |
| Product Code | JOJ |
| Date Received | 2018-05-09 |
| Model Number | ML02-0118 |
| Lot Number | OK157067 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-09 |