MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for PRISMAFLEX TPE PRISMAFLEX TPE 2000 SET 107144 manufactured by Gambro Industries.
[72801859]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72801860]
A patient was receiving therapeutic plasma exchange (tpe) using a prismaflex tpe 2000 set and a prismaflex control unit. Air was reportedly observed in the set prior to start requiring three additional priming cycles of the set. In relation to patient connection, the prismaflex control unit generated an alarm and the operator reportedly observed an effluent fluid leak at the level of the effluent pump segment of the prismaflex tpe 2000 set. The treatment was discontinued without blood restitution, causing a blood loss of 125 ml. According to additional provided information, the treatment was restarted using a new prismaflex tpe 2000 set. No further problem was reported. There is no information provided to reasonably suggest that the patient presented with any clinical symptoms or that any medical intervention was provided. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2017-00018 |
| MDR Report Key | 6485619 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-03-15 |
| Date Mfgr Received | 2017-03-17 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-04-12 |
| 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 | GAMBRO INDUSTRIES |
| Manufacturer Street | 7 AVENUE LIONEL TERRAY |
| Manufacturer City | MEYZIEU |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2017-04-12 |
| Model Number | PRISMAFLEX TPE 2000 SET |
| Catalog Number | 107144 |
| Lot Number | 16J0604 |
| ID Number | N/A |
| Device Expiration Date | 2019-10-01 |
| 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 | 2017-04-12 |