MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-08 for MINNCARE 500ML WEEKLY WRO - W300H manufactured by Gambro.
[16305492]
Portable ro 28948 - after weekly disinfection with minncare, machines continue to show positive residue. After rinsing for 24 hrs, still shows a positive residual. Turned off and back on showed a negative residual. Turned off and then back on and showed a positive residual when on minncare used on the ro machine. This was (b)(6) 2014. On (b)(6) 2014 machine was send to our biomed dept and the same problem continued. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037753 |
| MDR Report Key | 4024488 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-06-24 |
| Date Added to Maude | 2014-08-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | MINNCARE 500ML WEEKLY |
| Generic Name | WRO 300 PORTABLE RO |
| Product Code | LIF |
| Date Received | 2014-08-08 |
| Model Number | WRO - W300H |
| Lot Number | 741143 |
| Device Expiration Date | 2015-04-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | 14550 28TH AVE. NORTH PLYMOUTH MN 55447 US 55447 |
| Brand Name | MINNCARE RESIDUAL STRIPS |
| Generic Name | NONE |
| Product Code | LIF |
| Date Received | 2014-08-08 |
| Lot Number | 736923 |
| Device Expiration Date | 2015-06-01 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | 14550 28TH AVE NORTH PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-08 |