FDA Adverse Event
Other
Summary report: N
NA
MDR report key: 1416706
·
Received May 14, 2009
Report
- Report Number
- 2090040-2009-00002
- Event Type
- Other
- Date Received
- May 14, 2009
- Date of Event
- April 1, 2009
- Report Date
- May 1, 2009
- Manufacturer
- ASCENT HEALTHCARE SOLUTIONS
- Product Code
- NQG
- PMA / PMN Number
- K070036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO ASCENT HEALTHCARE SOLUTIONS WITHOUT ANY LABELING OR SALES ORDER INFO. THEREFORE, THE LOT NUMBER, MANUFACTURE DATE AND EXPIRATION DATE COULD NOT BE DETERMINED. THE CUSTOMER STATED THAT A CANISTER WAS NOT USED WITH THE STABILIZER BECAUSE THEY DID NOT HAVE ONE THAT FIT THE DEVICE. ASCENT HEALTHCARE SOLUTION'S IFU STATES: "CONNECT OTHER END OF THE NON-FILTER TUBING SET TO A FLUID COLLECTION CONTAINER (NOT SUPPLIED)."
Description of Event or Problem · 1
THE CUSTOMER WAS USING A TISSUE STABILIZER IN AN OPEN HEART OFF PUMP PROCEDURE WITHOUT THE CANISTER AND REPORTED THAT BLOOD BACKED UP IN THE TUBING AND THE MACHINE SHUT DOWN. THE PROCEDURE TIME WAS EXTENDED BY 30 MINS. THERE WAS NO PT INJURY OR ADVERSE OUTCOME REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | NQG | ASCENT HEALTHCARE SOLUTIONS | 29400-K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |