FDA Adverse Event
Malfunction
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 2505452
·
Received March 16, 2012
Report
- Report Number
- 1212122-2012-00008
- Event Type
- Malfunction
- Date Received
- March 16, 2012
- Date of Event
- February 19, 2012
- Report Date
- February 20, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- OEZ
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO RECEIVED THE ACTUAL DEVICE; HOWEVER, FURTHER INVESTIGATION IS NECESSARY. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS SURGERY, "WHILE ON BYPASS, THE CUSTOMER NOTICED BLOOD DRIPPING OUT OF OXYGENATOR INLET." THE PRODUCT WAS NOT CHANGED OUT, THERE WAS 1 CC BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY, THERE WAS NO DELAY IN SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOVASCULAR PROCEDURE KIT | CONVENIENCE TUBING PACK | OEZ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | NA | NP12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |