Cases of adverse events associated with blood transfusion-related medical devices (2013∼2022)
| Case | Device | Model | Medical device problem |
Clinical signs, symptoms and conditions |
Health impact |
Year of report |
|---|---|---|---|---|---|---|
| 1 | LRF | NA (Haemonetics corporation, MA, USA) | A1408_ No flow | E2403_No clinical signs, symptoms or conditions | F05_Delay to treatment/ therapy F2301_Additional device required |
2013 |
| 2 | LRF | NA (Haemonetics corporation, MA, USA) | A050401_Fluid leak | E2403_No clinical signs, symptoms or conditions | F1004_Underdose | 2013 |
| 3 | LRF | NA (Haemonetics corporation, MA, USA) | A140902_Partial blockage | E2403_No clinical signs, symptoms or conditions | F05_Delay to treatment/ therapy F2301_Additional device required |
2014 |
| 4 | BTS | NA (Doowon meditec corporation, Korea) | A050401_Fluid leak | E2403_No clinical signs, symptoms or conditions | F2301_Additional device required | 2015 |
| 5 | LRF | NA (Haemonetics corporation, MA, USA) | A1408_ No flow | E2403_No clinical signs, symptoms or conditions | F2301_Additional device required | 2015 |
| 6 | LRF | NA (Haemonetics corporation, MA, USA) | A1408_ No flow | E2403_No clinical signs, symptoms or conditions | F2301_Additional device required | 2015 |
| 7 | LRF | NA (Haemonetics corporation, MA, USA) | A050401_Fluid leak | E2403_No clinical signs, symptoms or conditions | F2301_Additional device required | 2016 |
| 8 | LRF | RC2VAE (Haemonetics corporation, MA, USA) | A050401_Fluid leak | E2403_No clinical signs, symptoms or conditions | F1004_Underdose, F2301_Additional device required |
2016 |
| 9 | LRF | RC2VAE (Haemonetics corporation, MA, USA) | A040101_Fracture | E2403_No clinical signs, symptoms or conditions | F2301_Additional device required | 2018 |
| 10 | BTS | 903-00004 (Belmont instrument corporation, CA, USA) | A050401_Fluid leak | E2403_No clinical signs, symptoms or conditions | F2301_Additional device required | 2021 |
| 11 | BTS | 903-00006 (Belmont instrument corporation, CA, USA) | A040101_Fracture | E2403_No clinical signs, symptoms or conditions | F2301_Additional device required | 2021 |
| 12 | LRF | RC2VAE (Haemonetics corporation, MA, USA) | A1408_ No flow | E2403_No clinical signs, symptoms or conditions | F2301_Additional device required | 2022 |
*International Medical Device Regulators Forum codes were used to classification (code_term); A1408_ No flow, A050401_Fluid leak, A140902_Partial blockage, A040101_Fracture, E2403_No clinical signs, symptoms or conditions, F05_Delay to treatment/ therapy, F2301_Additional device required, F1004_Underdose.
Abbreviations: LRF, leukocyte reduction filter; NA, not available; BTS, blood transfusion set.