FDA Adverse Event
Malfunction
Summary report: N
EXCOR
MDR report key: 23412818
·
Received October 29, 2025
Report
- Report Number
- 23412818
- Event Type
- Malfunction
- Date Received
- October 29, 2025
- Date of Event
- August 21, 2025
- Report Date
- September 11, 2025
- Manufacturer
- BERLIN HEART GMBH
- Product Code
- DSQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE DRIVE LINE FELL OUT OF THE BERLIN HEART CHAMBER. THE NURSE QUICKLY TOOK THE DRIVE LINE TUBING AND RECONNECTED IT TO THE BERLIN HEART CHAMBER. PERFUSION WAS NOTIFIED, BERLIN HEART COMPANY WAS CALLED, AND THE BERLIN HEART WAS REPLACED. THE BERLIN HEART CHANGE OUT REQUIRED INTUBATION BECAUSE HE WAS NOT ADEQUATELY NPO [NOTHING BY MOUTH] FOR THIS UNPLANNED BUT URGENT PROCEDURE. HE WAS ABLE TO BE EXTUBATED SHORTLY AFTER THE PROCEDURE AND HAD NO PERMANENT OR SERIOUS HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2718995 | EXCOR | VENTRICULAR (ASSISST) BYPASS | DSQ | BERLIN HEART GMBH | P25P | 2330950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Male | Other |