MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for CELLEX SYSTEM manufactured by Therakos, Inc /mallinckrodt Pharmaceuticals Ireland Ltd..
[180630648]
Pulmonary emboli (pe) was diagnosed in a pt who had received 12 extracorporeal photopheresis (ecp) treatments via the cellex system for bronchiolitis obliterans syndrome (bos). The pt had received his 12th ecp treatment (b)(6) 2020 and the event occurred (b)(6) 2020. The pi reported a possible relationship. Subject presented to the ed on (b)(6) 2020 with complaints of acute onset dyspnea earlier that morning. He took his pulse oximetry which dipped to the mid 80s as well as heart rate into the 140s, symptoms occurring only with exertion. Subject was started on heparin drip and underwent ir guided catheter directed thrombolysis using tpa on (b)(6) 2020. Tpa was stopped on (b)(6) 2020 and heparin was continued. On (b)(6) 2020, warfarin was started and pt remained in the hosp for warfarin bridging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093086 |
| MDR Report Key | 9729054 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-18 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLEX SYSTEM |
| Generic Name | SYSTEM, PHOTOHERESIS, EXTRACORPOREAL |
| Product Code | LNR |
| Date Received | 2020-02-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERAKOS, INC /MALLINCKRODT PHARMACEUTICALS IRELAND LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-02-18 |