FDA Adverse Event
Malfunction
Summary report: N
THERMODILUTION BALLOON CATHETER
MDR report key: 368362
·
Received December 20, 2001
Report
- Report Number
- 2243801-2001-00030
- Event Type
- Malfunction
- Date Received
- December 20, 2001
- Date of Event
- October 11, 2001
- Report Date
- December 17, 2001
- Manufacturer
- B. BRAUN MEDICAL INC./HOSPITAL DIVISION
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RETURN REASON: PRESSURE WAVES DID NOT APPEAR ON MONITOR. ANALYSIS: INVESTIGATION FOUND WIRE BROKE OFF AT SOLDER AREA. ALSO NOTE, STOPCOCK IS CRACKED. ORIGIN UNKNOWN. REMEDIAL ACTION: MANUFACTURING AND QUALITY ASSURANCE HAVE BEEN NOTIFIED. EACH THERMISTOR IS 100% VISUALLY AND CONTINUITY TESTED. BOTH THE FREQUENCY AND SEVERITY TO THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINE IF FURTHER REMEDIAL ACTION IS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57776 | THERMODILUTION BALLOON CATHETER | FLOW-DIRECTED BALLOON CATHETER | DYG | B. BRAUN MEDICAL INC./HOSPITAL DIVISION | TD-110-7H | 0060183412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |