FDA Adverse Event
Malfunction
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 1983305
·
Received February 4, 2011
Report
- Report Number
- 1212122-2011-00008
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 12, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- OEZ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO DID NOT RECEIVE THE ACTUAL DEVICE AND FURTHER INFORMATION 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 DURING CARDIOPULMONARY BYPASS SURGERY, THE CARDIOPLEGIA LINE LEAKED AT THE FEMALE-LUER CONNECTION. THE PRODUCT WAS CHANGED OUT, THERE WAS 40 ML 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |