MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-21 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[185974278]
Lot number and expiry are unknown at this time. Investigation is in process. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[185974279]
During a customer site visit, a terumo bct representative was informed by the customer of a patient reaction that had occurred during a red blood cell exchange (rbcx) procedure. Per the customer, this was the patient's third or fourth rbcx. The patient experienced a rash, was itchy, complained of palpitations, was tachycardic, dizzy and complained of feeling like her throat was swelling, but upon examination no swelling was observed. The doctor at the customer site believes the reaction may have due to ethylene oxide (eto). An ig test was ordered to determine if it was an eto reaction, however, results are not available at this time. It is unknown at this time if any medical intervention was necessary for the patient reaction. Patient identifier, age, weight, and outcome are not available at this time. Exact incident date is unknown at this time. 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 | 1722028-2020-00076 |
| MDR Report Key | 9739777 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| 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 | 2020-02-21 |
| Catalog Number | 10220 |
| 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 | 2020-02-21 |