MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-13 for IMUFLEX BLOOD BAG SYSTEM 1BBWGQ506A2 manufactured by Terumo Corporation.
[182929752]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[182929753]
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). Terumo bct is awaiting return of the disposable set.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9681839-2020-00010 |
MDR Report Key | 9707372 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-02-13 |
Date of Report | 2020-02-13 |
Date of Event | 2020-01-13 |
Date Mfgr Received | 2020-02-17 |
Date Added to Maude | 2020-02-13 |
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 4180004 |
Manufacturer Postal | 4180004 |
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 | 2020-02-13 |
Returned To Mfg | 2020-01-27 |
Catalog Number | 1BBWGQ506A2 |
Lot Number | 181025AF |
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 | 2020-02-13 |