MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-03 for MESA LABORATORIES 7.0 PH SOLUTION 02.0031 manufactured by Mesa Laboratories.
[4346591]
A 7. 0 ph solution from (b)(4) recalled. This solution is used to calibrate phoenix meters which are used to test ph and conductivity on our dialysis machines. First alert sent out from mesa laboratories on (b)(6) indicating 'bacteria growth' in 7. 0 ph solution. Alert informs us to sequester all affected bottles of 7. 0 ph solutions. Solution sequestered on (b)(6) 2013. All dialysis machines heat or bleach disinfected per the first alert. Second alert sent out on (b)(6). This alert changes terminology from 'bacteria growth' to 'mold. ' alert informs us to perform bleach disinfection on all dialysis machines. Machines disinfected per the alert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3670470 |
| MDR Report Key | 3670470 |
| Date Received | 2013-10-03 |
| Date of Report | 2013-10-02 |
| Date of Event | 2013-09-25 |
| Date Added to Maude | 2014-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MESA LABORATORIES 7.0 PH SOLUTION |
| Generic Name | MESA LABORATORIES 7.0 PH SOLUTION |
| Product Code | FKH |
| Date Received | 2013-10-03 |
| Catalog Number | 02.0031 |
| Lot Number | ML-P7-1148 |
| Device Expiration Date | 2014-09-14 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MESA LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-03 |