MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-31 for PRISMAFLEX TPE 107144 manufactured by Baxter Healthcare Corporation.
[177267796]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177267797]
It was reported that during therapeutic plasma exchange (tpe) treatment using a prismaflex tpe 2000 set, the patient experienced hyperkalemia. It was reported the patient? S potassium concentration was? Raised from 6. 0 mmol/l and then increased to 8. 3 mmol/l? (at the end of the treatment). It was reported that potassium was not added to any of the products or solutions during treatment. No patient symptoms were reported. It was reported the patient was transferred to the intensive care unit to be monitored and was? Provided with iec drug? (no further details). At the time of this report, the patient outcome was reported as? The patient is not presenting with hyperkalemia?. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2020-00006 |
| MDR Report Key | 9653106 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-31 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | BAXTER HEALTHCARE - MEYZIEU |
| Manufacturer Street | 7, AV LIONEL TERRAY, B.P. 126 |
| Manufacturer City | MEYZIEU CEDEX RHONE 69883 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69883 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX TPE |
| Generic Name | SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA |
| Product Code | MDP |
| Date Received | 2020-01-31 |
| Model Number | NA |
| Catalog Number | 107144 |
| Lot Number | 19D2601 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-31 |