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.
[186021146]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[186021147]
The customer reported that 3/4 of the way through a therapeutic plasma exchange (tpe) procedure on a patient with demyelinating disease and multiple sclerosis, they began seeing red tinged plasma going up to the remove bag and in the connector. Per the customer, the plasma was a typical yellow-tinged color at the start of the procedure and the hemolysis was not due to disease state or medication given. The operator had already disabled the rbc detector before contacting terumo bct as they had done this before on other procedures and thought this would resolve the issue. Per physician's order, the procedure was ended, and no medical intervention was necessary. The patient is reported as stable. The patient was an in-patient, so they decided to check the patient's cbc the following day, as already planned, and repeat the procedure the following monday, as already planned. The customer declined to provide the patient identifier. The exchange set was disposed of and is not available for return
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00044 |
| MDR Report Key | 9660510 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-11-12 |
| 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 |
| Lot Number | 1911123130 |
| 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 | 2020-02-03 |