FDA Adverse Event
Other
Summary report: N
ARROW TELEFLEX IABP (INTRA-AORTIC BALLOON PUMP)
MDR report key: 19089552
·
Received April 10, 2024
Report
- Report Number
- MW5153742
- Event Type
- Other
- Date Received
- April 10, 2024
- Report Date
- April 9, 2024
- Manufacturer
- ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
- Product Code
- DSP
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT'S IABP (INTRA-AORTIC BALLOON PUMP) BEGAN ALARMING FOR HIGH PRESSURE ALARMS CAUSING THE PUMP TO SHUT OFF AND NEED TO BE MANUALLY RESTARTED. PATIENT WAS REPOSITIONED TO BE AS FLAT AS POSSIBLE, AND THE LINE WAS INSPECTED TO ENSURE NO KINKS OR BENDING. IABP CONSOLE THEN ALARMED "SYSTEM ERROR 3, PUMP/VALVE CONTROLLER ERROR" AND SHUT OFF AGAIN. IABP ENGINEER WAS PAGED AND CAME TO INSPECT THE DEVICE. THE ALARM HAPPENED TWICE MORE AND THE CONSOLE WAS THEN REMOVED FROM SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832804 | ARROW TELEFLEX IABP (INTRA-AORTIC BALLOON PUMP) | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) | IAP-0700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |