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 2018-09-07 for CER-1R manufactured by Medivators.
[119644838]
It was reported that a facility was reprocessing endoscopes with their cer-1 automatic endoscope reprocessor (aer) with the incorrect amount of rinses per the high-level disinfectant labeling and aer instructions-for-use. The facility was using cidex opa hld which requires 3 rinses but their aer was set up with 2 rinses. There is potential that endoscopes may have contained hld residual after reprocessing which could cause chemical colitis or adverse reactions to patients. Medivators discovered that the facility originally had their aer setup for using rapicide hld which requires 2 rinses. The facility switched to using cidex opa and did not have the firmware chip replaced in their aer to incorporate the 3rd rinse per the hld and aer instructions. Medivators informed the customer of the required 3 rinses for use with cidex opa and switched the firmware chip in their unit to have the correct amount of rinses. Cidex opa labeling and instructions and medivators cer-1 user manual clearly state 3 rinses are required when using cidex opa to reprocess endoscopes. It is unknown how long the facility had been using cidex opa with the incorrect amount of rinses. There have been no reports of patient harm. This complaint will continue being monitored in medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[119644839]
It was reported that a facility was reprocessing endoscopes with their cer-1 automatic endoscope reprocessor (aer) with the incorrect amount of rinses per the high-level disinfectant labeling and aer instructions-for-use. The facility was using cidex opa hld which requires 3 rinses but their aer was set up with 2 rinses. There is potential that endoscopes may have contained hld residual after reprocessing which could cause chemical colitis or adverse reactions to patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2018-00059 |
| MDR Report Key | 7857564 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2018-09-07 |
| 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 |
| 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 | CER-1R |
| Generic Name | AUTOMATIC ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2018-09-07 |
| Model Number | CER-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-07 |