MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-28 for PRISMAFLEX TPE 115315 manufactured by Gambro Industries.
[74164510]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74164511]
A patient was receiving therapeutic plasma exchange (tpe) using a prismaflex tpe2000 set ckt and a prismaflex control unit. There was reportedly no issue during the priming of the set. One hour into treatment, the customer noticed that blood was leaking from the prismaflex tpe2000 set ckt, at the level of the connection of the access line to the blood pump segment. The tubing was reported to be slightly torn at this level. There was reportedly no alarm generated by the prismaflex machine. Due to this event, the treatment was stopped and then restarted using a new prismaflex tpe2000 set ckt. Reportedly, this external blood leakage caused a blood loss of 1 to 2 ml. There was reportedly no injury nor medical intervention related to this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2017-00024 |
| MDR Report Key | 6530060 |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-04-03 |
| Date Mfgr Received | 2017-04-04 |
| Date Added to Maude | 2017-04-28 |
| 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 | 2017-04-28 |
| Model Number | NA |
| Catalog Number | 115315 |
| Lot Number | 16C3103A |
| Device Expiration Date | 2019-03-01 |
| 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 | 2017-04-28 |