MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-17 for IMUFLEX BLOOD BAG SYSTEM 1BBLGQ506A6 manufactured by Terumo Corporation.
[70451470]
(b)(4). Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[70451471]
The customer reported that during whole blood unit filtration, the bypass valve did not prevent blood from going through the bypass line, resulting in possible wbc contamination. Customer stated plasma products were made, but not red cells and platelets. Wbc count is not available at this time. There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, 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
[73358753]
Investigation: the one-way valve was returned for evaluation. Upon magnified visual inspection, a jagged slit was observed in the built-in valve. Manufacturing and testing/inspection records were reviewed for this lot. No abnormalities were noted in the records that would have contributed to the issue. Five retention samples from this lot were tested for flow and no issues were noted with the samples. The valve assembly is purchased from a supplier. The valve was sent to the supplier for evaluation. The supplier identified an issue during production of the valve lot in question as the reason for the jagged slit. Root cause: the cause of the blood back-flow as experienced by the customer was determined to be a manufacturing defect of the one-way valve by the valve supplier. Corrective action: the supplier corrected the machine issue that caused the defect and introduced a visual-check step in the manufacturing process. Additionally, the supplier has changed the frequency of the maintenance on the slit mold.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681839-2017-00056 |
| MDR Report Key | 6412614 |
| Date Received | 2017-03-17 |
| Date of Report | 2017-03-17 |
| Date of Event | 2017-02-09 |
| Date Facility Aware | 2017-02-21 |
| Report Date | 2017-03-20 |
| Date Reported to Mfgr | 2017-03-20 |
| Date Mfgr Received | 2017-03-21 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2017-03-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVE KERN |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMUFLEX BLOOD BAG SYSTEM |
| Generic Name | IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER |
| Product Code | KSR |
| Date Received | 2017-03-17 |
| Returned To Mfg | 2017-03-02 |
| Catalog Number | 1BBLGQ506A6 |
| Lot Number | 160728AF |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 MO |
| 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 | 2017-03-17 |