MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-07 for RAPICIDE PA HIGH LEVEL DISINFECTANT ML02-0117 manufactured by Medivators.
[178345954]
The facility reported that they used the wrong high-level disinfectant (hld) in the automated endoscope reprocessor (aer). There was employee exposure to rapicide pa hld fumes. There is potential for chemical exposure symptoms to occur. The facility reported that the use of the incorrect chemistry was recognized right away, as the fumes were strong, and they needed to vent the room. Medivators field service engineer (fse) was dispatched to examine the aer for any damage. The medivators fse ensured that the unit was operating according to specifications. Medivators fse also reported that this facility has two different models of aer's in the same room, and although there are safeguards in place to prevent the wrong hld from being used, a new operator put rapicide pa part a hld into the dsd-201 aer rather than into the advantage aer. Medivators regulatory followed up with the facility in mid-january, and at that time they reported that three employees experienced exposure symptoms, and one of the three was treated in the emergency department. All are reported to have no lasting symptoms. It was reported that these three individuals were not wearing any personal protective equipment (ppe). No endoscopes were processed in the aer with the incorrect hld, therefore there is no patient procedural risk. There have been no reports of patient harm.
Patient Sequence No: 1, Text Type: N, H10
[178345955]
The facility reported that they used the wrong high-level disinfectant (hld) in the automated endoscope reprocessor (aer). There was employee exposure to rapicide pa hld fumes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2020-00006 |
| MDR Report Key | 9681269 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2019-11-05 |
| Date Added to Maude | 2020-02-07 |
| 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 | LAURIE WEIR |
| Manufacturer Street | 9800 59TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7638984328 |
| Manufacturer G1 | MEDIVATORS INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPICIDE PA HIGH LEVEL DISINFECTANT |
| Generic Name | HIGH LEVEL DISINFECTANT |
| Product Code | FEB |
| Date Received | 2020-02-07 |
| Model Number | ML02-0117 |
| 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 | 2020-02-07 |