MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for IMUFLEX BLOOD BAG SYSTEM 1BBWGQ506A2 manufactured by Terumo Corporation.
[185915402]
Investigation: the samples were not returned for investigation and the investigation was conducted based on the information provided. The lot number was unknown and possible lot numbers were estimated, which could be related to the customer, on the consignee list of the product in question (bb*wgq506a2); however, we were not able to find the data relating to the customer on the list. Review of the manufacturing record of the past year revealed that no abnormalities had been observed in the manufacturing process and the product had been manufactured as usual. The testing and inspection record of the past year was reviewed and confirmed that there had been no abnormalities in all release testing items including foreign matters. The product (bb*wgq506a2) conformed to the standards. A review of past complaints yielded one similar event. It was inferred that the cause of hemolysis/red-tinged plasma are the same as those stated in the root cause. Root cause: the reported incident may have occurred by a combination of the following common factors of hemolysis in blood products. Characteristics of blood there is a possibility of hemolysis if the blood of a donor has characteristics of red blood cell fragility. Bacterial contamination hemolysis is likely to occur if blood is contaminated with bacteria containing hemolysin. Excessively cooling blood is gradually congealed and eventually hemolyzed when it is cooled below -3? C. There is a possibility of hemolysis due to this factor if the blood bag is locally cooled in the refrigerator. Filter occlusion filtration time is extended because the filter is likely to be occluded, and furthermore, when red blood cells flow through such an occluded filter, physical stress on the red blood cells may cause hemolysis.
Patient Sequence No: 1, Text Type: N, H10
[185915403]
The customer reported hemolysis (red tinged plasma) in a filtered whole blood unit. After centrifugation of leukoreduced filtered unit, hemolysis was observed on the post-filtration plasma. The unit involved had a prolonged filtration time of greater than 2 hours. The units were quarantine and destroyed. 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 | 9681839-2020-00028 |
| MDR Report Key | 9897382 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Catalog Number | 1BBWGQ506A2 |
| 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 | 2020-03-30 |