FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 34 CC. IAB
MDR report key: 182190
·
Received August 11, 1998
Report
- Report Number
- 2248146-1998-00891
- Event Type
- Malfunction
- Date Received
- August 11, 1998
- Date of Event
- July 25, 1998
- Report Date
- July 29, 1998
- Manufacturer
- DATASCOPE CORPORATION
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-00942) THE IAB LEAKED. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PATIENT. ON 8/28/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE PUMP STARTED ALARMING AND BLOOD WAS NOTED IN THE TUBING. THE DOCTOR WAS NOTIFIED AND THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 7/29/98; NONE - REPORTED 8/28/98. [PATIENT'S CURRENT STATUS]: UNK - REPORTED 7/29/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 9.5 FR. 34 CC. IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORPORATION | 0684-00-0307 | 01/16/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |