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 2018-05-09 for PRISMAFLEX TPE 115315 manufactured by Baxter Healthcare - Meyzieu.
[108248811]
Facility name - the first hospital affiliated to (b)(6) medical university. The actual device was not available; however, a photograph of the sample was provided for evaluation. The visual inspection of the provided photograph shows that the pbp and effluent lines are incorrectly assembled on the support plate. The reported condition was verified. The cause of the condition was determined to be an operator error during manufacturing. To address this issue, awareness training was provided to all operators. The reported lot was manufactured prior to this action. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted
Patient Sequence No: 1, Text Type: N, H10
[108248812]
It was reported that the effluent line (yellow) was mismatched with the pre blood line (white) of a prismaflex tpe2000 set ckt. This was identified during priming. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2018-00039 |
| MDR Report Key | 7500757 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-09 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-04-14 |
| Date Mfgr Received | 2018-04-14 |
| Date Added to Maude | 2018-05-09 |
| 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 - 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 | 2018-05-09 |
| Model Number | NA |
| Catalog Number | 115315 |
| Lot Number | 17G1302A |
| Device Expiration Date | 2019-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-05-09 |