MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for CENTRISOL ACID CONCENTRATE SB-130 manufactured by Medivators Inc..
[68404814]
Patient Sequence No: 1, Text Type: N, H10
[68404815]
Two very different dialysis solutions (both acids) but with different ingredients have such similar labels that staff pulled the wrong item from supply. Mistake was caught before it was used, however concern that the labels should more clearly convey the difference such as different colors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6360550 |
| MDR Report Key | 6360550 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-01-19 |
| Date of Event | 2016-12-23 |
| Report Date | 2017-01-18 |
| Date Reported to FDA | 2017-01-18 |
| Date Reported to Mfgr | 2017-01-18 |
| Date Added to Maude | 2017-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRISOL ACID CONCENTRATE |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT |
| Product Code | FKQ |
| Date Received | 2017-02-27 |
| Model Number | SB-130 |
| Catalog Number | SB-130 |
| Lot Number | 820319 |
| Device Expiration Date | 2016-08-31 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-27 |