MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-12 for IMUFLEX BLOOD BAG SYSTEM 1BBWGQ506A2 manufactured by Terumo Corporation.
[185767667]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[185767668]
The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit. 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. Donor unit #: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681839-2020-00016 |
| MDR Report Key | 9827479 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-12-01 |
| Date Added to Maude | 2020-03-12 |
| 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 | YOSHIKI TAKAGI |
| Manufacturer Street | 818 MISONODAIRA |
| Manufacturer City | FUJINOMIYA 418-0004 |
| Manufacturer Postal | 418-0004 |
| Manufacturer Phone | 44277141 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMUFLEX BLOOD BAG SYSTEM |
| Generic Name | IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER |
| Product Code | CAK |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-02-20 |
| Catalog Number | 1BBWGQ506A2 |
| Lot Number | 190718AF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION |
| Manufacturer Address | FUJINOMIYA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |