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 2015-09-05 for MCB 214-100 BICARB SYSTEM manufactured by Mar Cor Purification.
[25098804]
Received initial report from clinic on 8. 7. 2015. Multiple contact attempts have been made along with messages left for dr. (b)(6) over the last 30 days requesting additional information. No additional information has been forthcoming.
Patient Sequence No: 1, Text Type: N, H10
[25098805]
Clinic called to report that while performing a bleach disinfect of their mcp system (hemodialysis dialysate bicarbonate mixer), the staff inadvertently sent the mixture to the patient floor. Potential of affecting 20 patients. Clinic was monitoring hemo levels and did not report any adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2015-00003 |
| MDR Report Key | 5059342 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-05 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-08-07 |
| Date Mfgr Received | 2015-08-07 |
| Date Added to Maude | 2015-09-05 |
| 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 | MS. MEGAN DICKEY |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCB 214-100 BICARB SYSTEM |
| Generic Name | TANK, HOLDING DIALYSIS |
| Product Code | FIN |
| Date Received | 2015-09-05 |
| Model Number | 214-100 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-05 |