AUTOCAT2 WAVE Adverse Event — Malfunction (MDR 1219856-2008-00058)
AUTOCAT2 WAVE Adverse Event — Malfunction (MDR 1219856-2008-00058) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AUTOCAT2 WAVE; Generic name: INTRA-AORTIC BALLOON PUMP PRODUCTS; Manufacturer: ARROW INTL., INC..
| Device | AUTOCAT2 WAVE |
|---|---|
| Generic name | INTRA-AORTIC BALLOON PUMP PRODUCTS |
| Manufacturer | ARROW INTL., INC. |
| Report number | 1219856-2008-00058 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Foreign, User facility |
| Narrative | IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED A SHEATH VIA THE RIGHT FEMORAL ARTERY. THE IAB WAS INSERTED WITHOUT INCIDENT. THE PT WAS MOVED TO THE INTENSIVE CARE UNIT. THE REGISTERED NURSE NOTICED BLOOD IN THE HELIUM TUBE DRIVELINE OF THE IAB; THE PUMP DID NOT ALARM. BECAUSE OF THE PTS CONDITION, IT WAS NOT POSSIBLE TO |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →