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 2017-12-15 for PRISMAFLEX TPE 107144 manufactured by Baxter Healthcare - Meyzieu.
[95825761]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[95825762]
It was reported that during patient treatment involving a prismaflex tpe2000 set, reportedly an external blood leakage was observed. The originating point and the amount of blood loss was not reported. 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 | 8010182-2017-00180 |
| MDR Report Key | 7122568 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-15 |
| Date of Report | 2018-02-27 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2018-02-07 |
| Date Added to Maude | 2017-12-15 |
| 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 | BAXTER HEALTHCARE - MEYZIEU |
| Manufacturer Street | 7, AV LIONEL TERRAY, B.P. 126 |
| Manufacturer City | MEYZIEU CEDEX RHONE 69883 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69883 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX TPE |
| Generic Name | SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA |
| Product Code | MDP |
| Date Received | 2017-12-15 |
| Model Number | NA |
| Catalog Number | 107144 |
| Lot Number | 17F2802 |
| ID Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - MEYZIEU |
| Manufacturer Address | MEYZIEU CEDEX RHONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-12-15 |