ADVANCED PERFUSION SYSTEM 1 Adverse Event — Malfunction (MDR 1828100-2020-00176)
ADVANCED PERFUSION SYSTEM 1 Adverse Event — Malfunction (MDR 1828100-2020-00176) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ADVANCED PERFUSION SYSTEM 1; Generic name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED; Manufacturer: TERUMO CARDIOVASCULAR SYSTEMS C
| Device | ADVANCED PERFUSION SYSTEM 1 |
|---|---|
| Generic name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Report number | 1828100-2020-00176 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE PERFUSIONIST ATTEMPTED TO CHANGE OUT THE HOSES AS A FIX TO THE ISSUE, BUT CALIBRATION STILL FAILED WITH THE NEW HOSES. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE ELECTRONIC PATIENT GAS SYSTEM (EPGS). HE ATTEMPTED TO CALIBRATE BUT THERE WAS NO FLOW. HE REMOVED THE OUTLET LINE FROM THE EPGS AND WAS ABLE TO CALIBRATE. HE TROUBLESHOT THE SETUP DOWNSTREAM FROM THE EPGS AND FOUND THE SPECTR |
| Source | openFDA MAUDE (device adverse events) |
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