MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-13 for GAMBRO REVACLEAR DIALYZER K6 manufactured by Gambro.
[4120333]
Pt was placed on the gambro revaclear dialyzer machine k6 and it was noticed that there was blood leaking in the dialyzer. The treatment was terminated prior to the blood fully circulating through the system. The patient was made safe and the nephrologist was notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033463 |
| MDR Report Key | 3525089 |
| Date Received | 2013-12-13 |
| Date of Report | 2013-12-12 |
| Date of Event | 2013-12-11 |
| Date Added to Maude | 2013-12-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMBRO REVACLEAR DIALYZER K6 |
| Generic Name | DIALYSIS MACHINE K6 |
| Product Code | FII |
| Date Received | 2013-12-13 |
| Lot Number | C413124601 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-13 |