FDA Adverse Event
Malfunction
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 2022029
·
Received March 10, 2011
Report
- Report Number
- 1212122-2011-00041
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 16, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- OEZ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO DID NOT RECEIVE THE ACTUAL DEVICE AND FURTHER INVESTIGATION IS NECESSARY. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE X-COATED TUBING WAS CLOUDY. THE PRODUCT WAS NOT CHANGED OUT, THERE WAS NO BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOVASCULAR PROCEDURE KIT | CONVENIENCE TUBING PACK | OEZ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | NA03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |