ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTION Adverse Event — Malfunction (MDR 3002809144-2020-00347)
ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTION Adverse Event — Malfunction (MDR 3002809144-2020-00347) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTION; Generic name: LEVEL SENSOR, BULK SOLUTION; Manufacturer: ABBOTT GMBH.
| Device | ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTION |
|---|---|
| Generic name | LEVEL SENSOR, BULK SOLUTION |
| Manufacturer | ABBOTT GMBH |
| Report number | 3002809144-2020-00347 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | CORRECTION/REMOVAL NUMBER: 3002809144-09/18/19-008-C. FURTHER INVESTIGATION INTO THIS ISSUE FOUND THAT RESULTS COULD HAVE BEEN IMPACTED BY A DEFICIENCY OF THE ALINITY CI BULK SOLUTION LEVEL SENSOR, WHERE A CRACK COULD HAVE DEVELOPED FROM ENVIRONMENTAL STRESS. A PRODUCT CORRECTION LETTER HAS BEEN ISSUED TO ALL WORLDWIDE CUSTOMERS WITH INSTALLED ALINITY I PROCESSING MODULE AND/OR ALINITY C PROCESSIN |
| Source | openFDA MAUDE (device adverse events) |
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