MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-02 for MESA LABORATORIES 7.0 PH SOLUTION 02.0031 AND 02.0032 manufactured by Mesa Laboratories Inc.
[3880623]
Rec'd notification of possible contamination of mesa laboratories 7. 0 ph solution on (b)(6) /2013. All inventory of this solution was removed by clinic mgr from clinical area and use of ph strips was instituted to check ph of dialysate in dialysis machines until further resolution to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3410542 |
| MDR Report Key | 3410542 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-09-30 |
| Date of Event | 2013-09-20 |
| Date Facility Aware | 2013-09-20 |
| Report Date | 2013-09-30 |
| Date Reported to FDA | 2013-10-01 |
| Date Added to Maude | 2013-10-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MESA LABORATORIES 7.0 PH SOLUTION |
| Generic Name | PH METER CALIBRATION SOLUTION |
| Product Code | FKH |
| Date Received | 2013-10-02 |
| Returned To Mfg | 2013-10-01 |
| Catalog Number | 02.0031 AND 02.0032 |
| Lot Number | ML-P7-1148 |
| Device Expiration Date | 2014-09-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MESA LABORATORIES INC |
| Manufacturer Address | LAKEWOOD CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-02 |