MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[177603764]
Investigation: per the customer, the plasma in connector is cherry dark color. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[177603765]
The customer reported that 5 minutes into a red blood cell exchange (rbcx) on a thalassemia patient using a spectra optia device, they received an alarm 'aim system detected rbc interface near top of channel'. Per the customer, the interface was described as only pink plasma. Per terumo bct customer support, the customer was told not to press continue and the verify with the doctor at the customer site that the hemolysis was due to the patient's condition. The doctor ordered to disconnect the patient and the unit of blood was sent to the lab for hemolysis testing. It was reported that the doctor also ordered the following labs for the patient: ua, hemoglobin microscopic, ldh-hemolyzed, ast, ald, total protein, alk phos, total bili, electrolyte panel, calcium, albumin, creatinine, bun, cbc with diff, reticulocytes, ferritin and retic. Per the customer the lab results are pending and the patient is stable. Patient age is not available at this time. The customer declined to provide patient id. 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 | 1722028-2020-00019 |
| MDR Report Key | 9575384 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-09-06 |
| Date Added to Maude | 2020-01-10 |
| 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 | GARY DARK |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3035425102 |
| 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 | 2020-01-10 |
| Catalog Number | 10220 |
| Lot Number | 1909093330 |
| 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 | 2020-01-10 |