FDA Adverse Event
Malfunction
Summary report: N
BLOWER MISTER WITH IV SETS
MDR report key: 2192988
·
Received July 21, 2011
Report
- Report Number
- 2242352-2011-00986
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Report Date
- June 29, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K030512
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE CB-1000 CO2 BACKED UP THROUGH THE DEVICE AND INTO THE IV BAG, CAUSING THE SALINE BAG TO EXPLODE. NO INCIDENT DATES, LOT NUMBERS, NUMBER OF OCCURRENCES OR ANY INFORMATION IS AVAILABLE FOR THE EVENTS. THE PRODUCT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOWER MISTER WITH IV SETS | CLAMPLESS BEATING HEART | GCJ | MAQUET CARDIOVASCULAR, LLC | CB-1000 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |