MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for REVACLEAR 400 114746L manufactured by Gambro Renal Products, Inc..
[184119270]
Blood leaking from dialyzer header 12 mins into treatment. Crack noted and treatment stopped. No blood return. Patient stable and no any sign of distress. New set up established and treatment restarted. Notified doctor. Ordered to write down the dialyzer lot number. No others.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9853294 |
| MDR Report Key | 9853294 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-10-12 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | REVACLEAR |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-19 |
| Model Number | 400 |
| Catalog Number | 114746L |
| Lot Number | C619407704 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 1101 JETER AVENUE OPELIKA AL 36801 US 36801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |