MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-27 for EFFLUENT BAG A6001 114423 manufactured by Baxter Healthcare - Brooklyn Park.
[93531821]
(b)(4). Therapy date: the event occurred sometime between (b)(6) 2017. The device was not returned; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[93531822]
The home patient observed leakages from three 5l effluent drain bags during use. The bags were reported to have disconnected from the tubing and leaked onto the floor. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003504604-2017-00054 |
| MDR Report Key | 7061332 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-27 |
| Date of Report | 2017-12-21 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - BROOKLYN PARK |
| Manufacturer Street | 7601 NORTHLAND DRIVE N SUITE 170 |
| Manufacturer City | MINNEAPOLIS MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EFFLUENT BAG |
| Generic Name | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES |
| Product Code | MON |
| Date Received | 2017-11-27 |
| Model Number | A6001 |
| Catalog Number | 114423 |
| Lot Number | A3314 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - BROOKLYN PARK |
| Manufacturer Address | BROOKLYN PARK MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-27 |