MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-13 for IMUFLEX BLOOD BAG SYSTEM 1BBWGQ506A2 manufactured by Terumo Corporation.
[185911941]
Lot number and expiry information are not available at this time investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[185911942]
The customer reported possible hemolysis 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. The collection set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681839-2020-00018 |
| MDR Report Key | 9829472 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Catalog Number | 1BBWGQ506A2 |
| 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 CORPORATION |
| Manufacturer Address | FUJINOMIYA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-13 |