FDA Adverse Event
Malfunction
Summary report: N
CAPIOX SX OXYGENATOR W/ HR X COATING
MDR report key: 3063385
·
Received April 11, 2013
Report
- Report Number
- 1124841-2013-00089
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 26, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTN
- PMA / PMN Number
- K002238
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS RECEIVED THE ACTUAL DEVICE; 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 PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SETUP, THE SAMPLING LINE CONNECTION LOOKED LOOSE. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SET UP. PRODUCT WAS NOT USED. SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155111 | CAPIOX SX OXYGENATOR W/ HR X COATING | BLOOD-GAS OXYGENATOR | DTN | TERUMO CARDIOVASCULAR SYSTEMS CORP. | NA | PP31 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |