MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for DIALYSIS BAG 401 manufactured by Nxstage Medical, Inc..
[118549439]
The nurse was adding an electrolyte mixture to this continuous dialysis bag when it ruptured, splashing electrolyte fluids into her eyes. She was off work for 2 weeks as a result of these corneal abrasions she sustained from this failure. Manufacturer response for dialysis bag, (brand not provided) (per site reporter). I believe purchasing has reached out to them to get replacement bags free of charge. Unknown if they are taking the bag rupture seriously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7826232 |
| MDR Report Key | 7826232 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-06-25 |
| Report Date | 2018-07-25 |
| Date Reported to FDA | 2018-07-25 |
| Date Reported to Mfgr | 2018-08-29 |
| Date Added to Maude | 2018-08-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | DIALYSIS BAG |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2018-08-29 |
| Model Number | 401 |
| Lot Number | Q1803631 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Manufacturer Address | 350 MERRIMACK ST LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-29 |