Adverse events associated with transfusion-related medical devices reported to MFDS and USFDA since 2016
| IMDRF code_term | No. of reported adverse event | |||
|---|---|---|---|---|
| MFDS | USFDA | |||
| Blood transfusion set (N=47) | Blood transfusion set (BRZ) (N=507) | Blood transfusion microfilter (CAK) (N=915) | ||
| Annex A Medical Device problem | ||||
| A0201_Product quality problem | 1 | 1 | 10 | |
| A0202_Defective component | 0 | 5 | 163 | |
| A0206_Device misassembled during manufacturing/shipping | 5 | 6 | 0 | |
| A0302_Device ingredient or reagent problem | 0 | 1 | 309 (A030202*: 302) | |
| A0401_Break | 6 | 25 | 2 | |
| A0404_Crack | 1 | 29 | 0 | |
| A0406_Material deformation | 3 | 15 | 0 | |
| A0410_Material perforation | 0 | 32 | 0 | |
| A0414_Material split, cut or torn | 2 | 18 | 0 | |
| A0504_Leak/splash | 18 (A050401*: 18) | 265 (A050401*: 260) | 1 | |
| A0904_Energy output problem | 0 | 0 | 21 | |
| A0908_Incorrect, inadequate or imprecise result or readings | 0 | 0 | 218 (A090807*: 74) (A090809*: 116) | |
| A1203_Disconnection | 0 | 100 | 0 | |
| A1403_Filling problem | 0 | 20 | 0 | |
| A1404_Filtration problem | 0 | 0 | 229 | |
| A1405_Improper flow or infusion | 5 | 29 | 117 | |
| A1408_No flow | 4 | 34 | 1 | |
| A1409_Obstruction of flow | 2 | 7 | 3 | |
| A1414_Priming problem | 0 | 14 | 0 | |
| A1801_Contamination | 2 | 14 | 74 | |
| A24_Adverse event without identified device or use problem | 0 | 0 | 547 | |
| A26_Insufficient information | 0 | 0 | 16 | |
| A27_Appropriate term/code not available | 1 | 5 | 47 | |
| Annex E Clinical signs, symptoms and conditions | ||||
| E0303_Hemolysis | 0 | 0 | 3 | |
| E0601_Arrhythmia | 0 | 1 | 0 | |
| E1022_Perforation of esophagus | 0 | 0 | 1 | |
| E2010_Needle stick/puncture | 0 | 0 | 3 | |
| E2105_Exposure to body fluids | 0 | 2 | 1 | |
| E2321_Low blood pressure/ hypotension | 0 | 0 | 4 | |
| E2330_Pain | 0 | 0 | 1 | |
| E2401_Insufficient information | 0 | 8 | 2 | |
| E2402_Appropriate term/code not available | 0 | 1 | 3 | |
| E2403_No clinical signs, symptoms or conditions | 47 | 497 | 897 | |
*IMDRF level 3 codes_term; A030202_Coagulation in device or device ingredient, A050401_Fluid leak, A090807_High readings, A090809_High test results.
Abbreviations: IMDRF, International Medical Device Regulators Forum; USFDA, United States food and drug administration; MFDS, Ministry of food and drug safety.