MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-30 for MINNCARE HD manufactured by Mar Cor Purification.
[71290050]
Investigation determined a short length of pipe, supplying the bicarbonate mixer with water, was not flushed/rinsed after disinfection. This small volume of water containing the chemical was used in the production of a large batch of bicarbonate solution, for use on patients. No device failure. Procedures for system disinfection/rinsing were not properly followed. This complaint will continue to be monitored through the mar cor complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[71290051]
It was reported to mar cor on (b)(6) 2017 that 39 dialysis patients were potentially exposed to low levels of minncare hd during dialysis. No adverse events to patients has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2017-00001 |
| MDR Report Key | 6447006 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-30 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-02-28 |
| Date Mfgr Received | 2017-02-28 |
| Date Added to Maude | 2017-03-30 |
| 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 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 | MINNCARE HD |
| Generic Name | DISINFECTANT, SUBSYSTEM, WATER PURIFICATION |
| Product Code | NIH |
| Date Received | 2017-03-30 |
| Lot Number | 841913 |
| Device Expiration Date | 2018-01-31 |
| Device Availability | * |
| 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 | 2017-03-30 |