MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for TERUFLEX BLOOD BAG SYSTEM 3BO356E8 manufactured by Terumo Bct.
[146064898]
Investigation: the customer reported that the blood bag was centrifuged at speed of 3320rpm within 13 minutes by a centrifuge kubota 9942. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[146064899]
The customer reported that after centrifuging, the plasma component had red color due tot he rupture of the red blood cells (rbc). There was not a transfusion recipient or patient involved at the time of whole blood processing, therefore no patient information is reasonably known at the time of the event. This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda. The teruflex blood bag set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2019-00076 |
| MDR Report Key | 8474015 |
| Date Received | 2019-04-02 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-02-24 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2018-11-23 |
| Date Added to Maude | 2019-04-02 |
| 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 | 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 | TERUFLEX BLOOD BAG SYSTEM |
| Generic Name | TRIPLE TB CPD/AS-5 350ML ENG |
| Product Code | KSR |
| Date Received | 2019-04-02 |
| Catalog Number | 3BO356E8 |
| Lot Number | 181123A251 |
| 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 | 2019-04-02 |