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 2018-11-21 for EFFLUENT BAG 114423 manufactured by Baxter Healthcare - Brooklyn Park.
[129185929]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[129185930]
It was reported that the effluent bags of a prismaflex machine were leaking. This event was discovered during an unspecified process step. 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 | 3003504604-2018-00004 |
| MDR Report Key | 8097696 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-21 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-10-19 |
| Date Facility Aware | 2018-10-30 |
| Date Mfgr Received | 2018-12-17 |
| Date Added to Maude | 2018-11-21 |
| 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 | 2018-11-21 |
| Model Number | NA |
| Catalog Number | 114423 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| 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 | MINNEAPOLIS MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-21 |