MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-31 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[188236153]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[188236154]
The customer reported that a neuromylitis opticia patient had a transfusion reaction during a therapeutic plasma exchange (tpe) procedure with albumin on a spectra optia device. Per the customer, 45 min into the run the patient's experienced shortness of breath, rash, their face was deep red, stuffy nose, scratchy throat and sweating. The procedure was ended 5 min later. Per the customer, once the procedure was stopped the catheter was flushed the symptoms were resolved and a blood transfusion work up was done. The customer reported that the patient did not have respiratory distress. The customer reported the patient had a treatment following this one and did fine with the albumin. The customer reported that patient is stable and the symptoms were resolved following the treatment. The customer declined to provide the patient identifier. The disposable set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00040 |
| MDR Report Key | 9654501 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-10-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOT HILDEN |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314970 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRA OPTIA |
| Generic Name | SPECTRA OPTIA EXCHANGE SET |
| Product Code | LKN |
| Date Received | 2020-01-31 |
| Catalog Number | 10220 |
| Lot Number | 1910293130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-31 |