FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 138610
·
Received December 15, 1997
Report
- Report Number
- 2248146-1997-01371
- Event Type
- Malfunction
- Date Received
- December 15, 1997
- Date of Event
- December 3, 1997
- Report Date
- December 5, 1997
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT: (CC# 97-01468) AFTER IABP FOR 20 HOURS, BLOOD WAS NOTED IN THE HELIUM LINE. ON 1/19/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: FRESH BLOOD WAS SEEN IN THE TUBING APPROXIMATELY 20 HOURS POST INSERTION. A LEAK WAS SUSPECTED IN THE BALLOON AT THE CATHETER/MEMBRANE JUNCTION AND IT WAS NOT DUE TO CALCIFICATION OF THE AORTA. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 12/5/1997; NONE - REPORTED 1/19/1998. [PT'S CURRENT STATUS]: UNKNOWN - RPT'D 12/5/1997.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 9.5 FR. 40 CC. IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0306 | 07/17/99 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |