MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-16 for PRISMAFLEX TPE N/A 107144 manufactured by Gambro Industries.
[75412994]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75412995]
A patient was treated in therapeutic plasma exchange (tpe), using a prismaflex tpe 2000 set and a prismaflex control unit. There was reportedly no issue during the priming of the set, but the customer noted a leakage from the effluent line of the set after treatment start. They reportedly noticed a hole in the line, causing the leakage. Treatment was discontinued and the extracorporeal blood circuit was returned to the patient. No medical intervention was needed due to the event. The event reportedly resulted in the loss of 100 ml of albumin for the patient. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2017-00032 |
| MDR Report Key | 6571094 |
| Date Received | 2017-05-16 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-05-23 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2017-05-16 |
| 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 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 | 3 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2017-05-16 |
| Returned To Mfg | 2017-05-03 |
| Model Number | N/A |
| Catalog Number | 107144 |
| Lot Number | 16H3001 |
| ID Number | N/A |
| Device Expiration Date | 2019-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-05-16 |