MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-19 for CER-2 CLMAC-MV2R manufactured by Medivators.
[28667327]
A medivators clinical specialist went to the facility to check on their medivators cer automated endoscope reprocessor (aer) disinfectant reservoir that was not heating properly. The facility was using rapicide high level disinfectant which has a use temperature of 35 degrees celsius. The reservoir temperature was displaying 21 degrees celsius. The clinical specialist informed the facility to either replace or repair the reservoir or switch to manual disinfection using opa. Reprocessing endoscopes at the incorrect temperature could result in scopes not being properly disinfected, therefore potential for patient cross-contamination. The clinical specialist followed up with the facility via email on (b)(6) 2015 and they had a new heated reservoir installed. To date, there have been no complaints of patient cross-contamination. This complaint will continue to be monitored within the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[28667328]
A medivators clinical specialist went to the facility to check on their medivators cer automated endoscope reprocessor (aer) disinfectant reservoir that was not heating properly. The facility was using rapicide high level disinfectant which has a use temperature of 35 degrees celsius. The reservoir temperature was displaying 21 degrees celsius. The clinical specialist informed the facility to either replace or repair the reservoir or switch to manual disinfection using opa. Reprocessing endoscopes at the incorrect temperature could result in scopes not being properly disinfected, therefore potential for patient cross-contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2015-00032 |
| MDR Report Key | 5159774 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-19 |
| Date of Report | 2015-10-19 |
| Date of Event | 2015-09-23 |
| Date Mfgr Received | 2015-09-23 |
| Device Manufacturer Date | 2006-01-30 |
| Date Added to Maude | 2015-10-19 |
| 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 | KRISTIN BERGESON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| 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 | CER-2 |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2015-10-19 |
| Model Number | CLMAC-MV2R |
| 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 | 2015-10-19 |