FDA Adverse Event
Malfunction
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 1743266
·
Received June 24, 2010
Report
- Report Number
- 1212122-2010-00021
- Event Type
- Malfunction
- Date Received
- June 24, 2010
- Date of Event
- June 2, 2010
- Report Date
- June 2, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- OEZ
- PMA / PMN Number
- 510K EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; THE RETURNED SAMPLE WAS DECONTAMINATED, VISUALLY EXAMINED AND FUNCTIONALLY TESTED. PRESSURE TESTING WAS PERFORMED AND NO LEAKS WERE FOUND. TERUMO IS STILL INVESTIGATING THIS ISSUE AND WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE ISOLATOR LINE LEAKED. THE PRODUCT WAS NOT CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOVASCULAR PROCEDURE KIT | CONVENIENCE TUBING PACK | OEZ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | NA | MD08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |