MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for STREAMLINE AIRLESS SYSTEM SET SL-2000M2095 manufactured by Medisystems Corp.
[138228257]
Arterial line connecting to dialyzer became disconnected; leading to a blood loss via the dialyzer being open on the bottom. Patient will require for hgb to be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084732 |
| MDR Report Key | 8401713 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-03-01 |
| Date Added to Maude | 2019-03-07 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STREAMLINE AIRLESS SYSTEM SET |
| Generic Name | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS |
| Product Code | KOC |
| Date Received | 2019-03-07 |
| Model Number | SL-2000M2095 |
| Lot Number | 81255006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDISYSTEMS CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-07 |