MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for EVA DUAL CHAMBER CONTAINER 3L H938905 manufactured by Baxter Healthcare Corporation.
[181991175]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[181991176]
It was reported that an exactamix 3000 ml dua l-chamber eva (ethylene vinyl acetate) bag leaked from unspecified location. This issue was identified? After spiking/start of infusion and subsequently took the bag?. The bag was filled with tpn (total parenteral nutrition). 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 | 1416980-2020-01177 |
| MDR Report Key | 9786857 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-04 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | THE METRIX COMPANY |
| Manufacturer Street | 4400 CHAVENELLE ROAD |
| Manufacturer City | DUBUQUE IA 52002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 52002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVA DUAL CHAMBER CONTAINER 3L |
| Generic Name | CONTAINER, I.V. |
| Product Code | KPE |
| Date Received | 2020-03-04 |
| Model Number | NA |
| Catalog Number | H938905 |
| Lot Number | 63630-A5354 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |