MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-18 for SPECTRA OPTIA 12220 manufactured by Terumo Bct.
[163003524]
Investigation: per the customer, the removed volume was 891 ml and the replacement volume was 958 ml. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[163003525]
During follow-up with the customer about custom prime, it was reported that the pediatric sickle cell patient completed the red blood cell exchange (rbcx) procedure on optia, but had a decrease in hematocrit (hct) that required a blood transfusion. Per the customer, the custom prime was not completed for this procedure because they did not have the luer to connect the inlet line to the rbc bag and the return line to the empty bag. It was also stated that they did not have an empty bag either. The patient was put on the bilevel positive airway pressure (bipap) machine at 100% at 50 minutes into the procedure. The customers hematologist was by the bedside during the procedure and notified that custom prime was not performed. Per the customer the patient is stable in the pedi- icu. The customer declined to provide the patient identifier. 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 | 1722028-2019-00304 |
| MDR Report Key | 9208105 |
| Date Received | 2019-10-18 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-09-22 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2019-07-05 |
| Date Added to Maude | 2019-10-18 |
| 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 COLLECT SET |
| Product Code | LKN |
| Date Received | 2019-10-18 |
| Catalog Number | 12220 |
| Lot Number | 1907033230 |
| 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 | 2019-10-18 |