MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-13 for RAPICIDE PA ML02-0117 manufactured by Medivators Inc..
[174925433]
A facility reported they were not using rapicide pa high level disinfectant (hld) test strips to check the minimum required concentration (mrc) of rapicide pa hld used in their automated endoscope reprocessor (aer). Mrc of the hld was not confirmed, thus there is potential that endoscopes were not adequately high-level disinfected. Medivators clinical education specialist (ces) was onsite to perform an in-service training for their aer and observed the technicians not using test strips after the cycle was complete. Medivators ces supplied the facility with a box of rapicide pa test strips and the facility staff used the test strips the rest of the day. The facility reported they were out of test strips for the last two working days and had reprocessed about 60 endoscopes. The nurse manager and sterilization supervisor were aware they were out of tests strips and reported they had some on order. The rapicide pa hld instructions for use states to check the use solution with an rapicide pa test strip to ensure that it is above mrc. There have been no reports of patient harm or adverse event. This complaint will continue being monitored in medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[174925434]
A facility reported they were not using rapicide pa high level disinfectant (hld) test strips to check the minimum required concentration (mrc) of rapicide pa hld used in their automated endoscope reprocessor (aer). Mrc of the hld was not confirmed, thus there is potential that endoscopes were not adequately high-level disinfected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2020-00001 |
| MDR Report Key | 9582032 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2019-12-23 |
| Date Added to Maude | 2020-01-13 |
| 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 | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPICIDE PA |
| Generic Name | HIGH LEVEL DISINFECTANT |
| Product Code | MED |
| Date Received | 2020-01-13 |
| Model Number | ML02-0117 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | 14605 28TH AVE N PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-13 |