MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for SPECTRA OPTIA 12320 manufactured by Terumo Bct.
[185752099]
Investigation is in process. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[185752100]
The customer reported that a patient had a transfusion reaction during a car-t cell collection procedure on a spectra optia device. Per the customer the patient received a platelet transfusion prior to a car-t cell collection procedure because the patients platelet count was 3000. During the procedure, the doctor ordered another unit of platelets to be transfused. The platelets were being transfused on a separate infusion line. Per the customer this is when the patient had a transfusion reaction. The procedure was paused for more than 35 minutes to treat the transfusion reaction. The attending physician ordered 50mg benadryl be administered via infusion port. The customer is not alleging anything wrong with the specta optia device or disposable set. Per the customer the procedure was completed and the final yield was great, the customer was able to collect double the amount of cells that they needed for transplant. Per the customer the patient recovered from the reaction and is in stable condition. Patient identifier is unknown at this time. The customer declined to provide patient age. 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 | 1722028-2020-00144 |
| MDR Report Key | 9889304 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-12-10 |
| Date Added to Maude | 2020-03-27 |
| 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 IDL SET |
| Product Code | LKN |
| Date Received | 2020-03-27 |
| Model Number | 12320 |
| Catalog Number | 12320 |
| Lot Number | 1912093130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-27 |