MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-03 for SPECTRA OPTIA 12220 manufactured by Terumo Bct.
[186020911]
Manufacture date, expiry date and lot number are not available at this time. Investigation: a terumo bct service technician checked out the machine at the customer site. An autotest and saline run were completed successfully. The machine met all manufacturer's specifications. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[186020912]
The customer reported receiving the alarm "cells were detected in plasma line from centrifuge" and seeing pink- tinged plasma in the connector and plasma line during a red blood cell exchange (rbcx) procedure on a sickle cell patient. The machine was paused, and the physician was called. The physician at the site stated that the reason of discolored plasma is because the many antibodies that the patient has and that it was very hard to find the compatible units. Per the physician's order, a second unit was set up for a second attempt. Pink plasma was seen again on the second attempt. The machine was paused again, and the doctor ordered a test for transfusion reaction/hemolysis and ordered to stop the rbcx procedure. Test results are not available at this time. The patient was able to go home after the labs were drawn. Red blood cell replacement volume during first procedure: 140ml, lot no. 1911133230 red blood cell replacement volume during second procedure: 95ml, lot no. 1909183130 patient identifier and age are not available at this time. The rbcx sets are not available for return because they were discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00047 |
| MDR Report Key | 9661384 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-02-03 |
| 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 | 2020-02-03 |
| Catalog Number | 12220 |
| 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 | 2020-02-03 |