MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-16 for PRISMAFLEX TPE PRISMAFLEX TPE 1000 107143 manufactured by Gambro Industries.
[50636223]
A pediatric patient in (b)(6) was undergoing therapeutic plasma exchange treatment (tpe) for guillain-barre syndrome. The tpe set was connected via an extracorporeal membrane oxygenation (ecmo) circuit with smith stopcocks. At the completion of the tpe treatment, kelly clamps were used to disconnect the tpe access line from the ecmo circuit and the male luer broke off in the stopcock. The blood in the extracorporeal circuit was not returned to the patient resulting in an estimated blood loss of 71 ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2016-00059 |
| MDR Report Key | 5800206 |
| Date Received | 2016-07-16 |
| Date of Report | 2016-07-15 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-06-18 |
| Date Added to Maude | 2016-07-16 |
| 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 Contact | THIERRY PALKOVICS |
| Manufacturer Street | 7 AVENUE LIONEL TERRAY |
| Manufacturer City | MEYZIEU |
| Manufacturer Country | FR |
| Manufacturer Phone | 472452525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2203-2014 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2016-07-16 |
| Model Number | PRISMAFLEX TPE 1000 |
| Catalog Number | 107143 |
| Lot Number | 14G0206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| 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 | 2016-07-16 |