FDA Adverse Event
Malfunction
Summary report: N
BLOWER MISTER WITH IV SETS
MDR report key: 2201737
·
Received August 4, 2011
Report
- Report Number
- 2242352-2011-01037
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 12, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY BEING INVESTIGATED AND THE RESULTS ARE BEING EVALUATED AND ANALYZED WITH SIMILAR EVENTS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETE. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE CB-1000 BLOWER MISTER WAS LEAKING. THE REPORTER STATED THAT IT WAS LEAKING AROUND THE AREA BETWEEN THE PLASTIC AND METAL. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOWER MISTER WITH IV SETS | CLMAPLESS BEATING HEART | GCJ | MAQUET CARDIOVASCULAR, LLC | CB-1000 | 96255348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |