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 2015-10-24 for MEDIVATOR CER-2 OPTIMA manufactured by Medivators.
[29174797]
It was reported that positive cultures of mycobacterium were found in patients that had bronchoscopy procedures with endoscopes that were disinfected in a medivators cer-2 optima automated endoscope reprocessor. The facility mentioned that they tested patient cultures by flushing the cultures with sterile water at the end of the procedure and then tested that sample which tested positive. No actual patient biopsy pieces were tested for the bacteria. It was also reported that incoming unfiltered facility water tested positive for mycobacterium as well as the aer's basin drain, post filtration water, and water coming from hookups. It was predicted this bacteria was in the water not the patient. Medivators clinical specialist and medivators technical specialist has been in contact with this facility. Recommendations were made to the facility that the 1. 0 and 0. 2 micron filters be changed and replaced with medivators brand filters, and a waterline disinfection be performed. It was also recommended that additional cultures be obtained from the water exiting the hookup connectors immediately after wld. The facility has yet to share or contact medivators with the results of this evaluation, therefore conclusion not yet available. The cer-2 optima was evaluated and was operating according to specification. Medivators rapicide gluaraldehyde hld have been tested to successfully kill mycobacterium. There are no reports of patient related infections from this organism. This complaint will continue to be monitored and maintained within medivators complaint system.
Patient Sequence No: 1, Text Type: N, H10
[29174798]
It was reported that positive cultures of mycobacterium were found in patients that had bronchoscopy procedures with endoscopes that were disinfected in a medivators cer automated endoscope reprocessor.
Patient Sequence No: 1, Text Type: D, B5
[47254556]
It was reported that positive cultures of mycobacterium were found in patients that had bronchoscopy procedures with endoscopes that were disinfected in a medivators cer-2 optima automated endoscope reprocessor. The facility mentioned that they tested patient cultures by flushing the cultures with sterile water at the end of the procedure and then tested that sample which tested positive. No actual patient biopsy pieces were tested for the bacteria. It was also reported that incoming unfiltered facility water tested positive for mycobacterium as well as the aer's basin drain, post filtration water, and water coming from hookups. It was predicted this bacteria was in the water not the patient. Medivators clinical specialist and medivators technical specialist has been in contact with this facility. Recommendations were made to the facility that the 1. 0 and 0. 2 micron filters be changed and replaced with medivators brand filters, and a waterline disinfection be performed. It was also recommended that additional cultures be obtained from the water exiting the hookup connectors immediately after wld. The facility has yet to share or contact medivators with the results of this evaluation, therefore conclusion not yet available. The cer-2 optima was evaluated and was operating according to specification. Medivators rapicide gluaraldehyde hld have been tested to successfully kill mycobacterium. There are no reports of patient related infections from this organism. This complaint will continue to be monitored and maintained within medivators complaint system. On may 16th, 2016 - medivators field staff received notice that this facility continues to have issues with their scopes testing positive for mycobacterium cultures. It has been determined that this facility is not performing water line disinfection correctly. During investigation, it was discovered that they were not using the appropriate contact time for sanitizing at ambient temperature in accordance with the rapicide glutaraldehyde hld instructions for use. Medivators clinical staff and microbiology director has been in close contact with this facility to examine their processes. Medivators has requested samples from the facility so an internal investigation can be conducted by medivators micro team. To date, no samples have been returned. No reported patients affected.
Patient Sequence No: 1, Text Type: N, H10
[47254557]
It was reported that positive cultures of mycobacterium were found in patients that had bronchoscopy procedures with endoscopes that were disinfected in a medivators cer automated endoscope reprocessor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2015-00033 |
| MDR Report Key | 5173650 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-10-24 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-09-23 |
| Date Mfgr Received | 2015-09-23 |
| Device Manufacturer Date | 2014-06-30 |
| Date Added to Maude | 2015-10-24 |
| 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 | MEGAN DICKEY |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533327 |
| 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 | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIVATOR CER-2 OPTIMA |
| Generic Name | AUTOMATED ENDOSCOPE CLEANER WASHER |
| Product Code | NVE |
| Date Received | 2015-10-24 |
| Model Number | CER-2 OPTIMA |
| Device Availability | Y |
| Device Age | DA |
| 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. Hospitalization | 2015-10-24 |