FDA Adverse Event
Malfunction
Summary report: N
HOLLOW FIBER OXY WEST VERSION
MDR report key: 3063423
·
Received April 12, 2013
Report
- Report Number
- 9681834-2013-00052
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 26, 2013
- Manufacturer
- TERUMO CORPORATION, ASHITAKA
- Product Code
- DTZ
- PMA / PMN Number
- K051997
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT AFTER CARDIOPULMONARY BYPASS SURGERY, THE OXYGENATOR DID NOT MOVE THE PLASMALYTE AND REMAINING BLOOD FROM THE CARDIOPULMONARY BYPASS CIRCUIT TO THE CELL WASHER. THE DILUTED BLOOD WAS NOT COLLECTED AND PROCESSED AS PER THE USER FACILITY'S NORMAL PROCEDURE. A 50 ML BLOOD LOSS. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159521 | HOLLOW FIBER OXY WEST VERSION | BLOOD-GAS OXYGENATOR | DTZ | TERUMO CORPORATION, ASHITAKA | NA | 121208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |