MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-22 for PRISMAFLEX TPE PRISMAFLEX TPE 2000 107144 manufactured by Gambro Industries.
[68280613]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68280614]
A patient in (b)(6) was under therapy with a prismaflex tpe 2000 set. Reportedly, after connecting the patient the user identified the luer lock on the return line was found broken. The blood in the extracorporeal circuit was returned to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2017-00013 |
| MDR Report Key | 6349485 |
| Date Received | 2017-02-22 |
| Date of Report | 2017-02-22 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | 2249487578 |
| Manufacturer G1 | GAMBRO INDUSTRIES |
| Manufacturer Street | 7 AVENUE LIONEL TERRAY |
| Manufacturer City | MEYZIEU |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2193-2014 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2017-02-22 |
| Model Number | PRISMAFLEX TPE 2000 |
| Catalog Number | 107144 |
| Lot Number | 16F2102Z |
| Device Expiration Date | 2018-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO INDUSTRIES |
| Manufacturer Address | 7 AVENUE LIONEL TERRAY MEYZIEU 69883 FR 69883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-22 |