MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-07 for IMUFLEX BLOOD BAG SYSTEM 1BBWGQ506A2 manufactured by Terumo Corporation.
[182232366]
Investigation: the blood bag set was not returned for evaluation. The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found. The records regarding the particulate removal rates of the filter membranes were reviewed. All membranes conformed to established specification. Shipping testing was performed on the reserve samples from the reported lot number. The reserve samples were also visually examined, and the solution volume and solution composition were tested with no abnormalities noted. All product conformed to the established specification. Regarding the reported lot number, we reviewed whether there had been any complaints reported by other customers. The results revealed that complaints against wbc contamination associated with this lot number had not been reported by any other customers as of january 20, 2020. Root cause: we reviewed the manufacturing record and the testing and inspection record of the reported lot number; however, we did not find any abnormalities and we were not able to identify the cause of the issue.
Patient Sequence No: 1, Text Type: N, H10
[182232367]
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) 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 | 9681839-2020-00004 |
| MDR Report Key | 9681388 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-07 |
| 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 Country | JP |
| 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 | 2020-02-07 |
| Catalog Number | 1BBWGQ506A2 |
| Lot Number | 190311AG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION |
| Manufacturer Address | FUJINOMIYA JP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |