FDA Adverse Event
Malfunction
Summary report: N
XPOSE 3 DEVICE
MDR report key: 2240916
·
Received August 17, 2011
Report
- Report Number
- 2242352-2011-01218
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 15, 2011
- Report Date
- August 15, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- MWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS THE PRODUCT LOT NUMBER IS UNKNOWN. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE XPOSE 3 TUBING CLOTTED, STOPPED SUCTIONING AND THE HEART DROPPED. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPOSE 3 DEVICE | CLAMPLESS BEATING HEART | MWS | MAQUET CARDIOVASCULAR, LLC | XP-3000 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |