FDA Adverse Event
Summary report: N
UHC CUSTOM X-COATED ADULT PACK
MDR report key: 1982433
·
Received January 25, 2011
Report
- Report Number
- 1124841-2011-00007
- Date Received
- January 25, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 5, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- OEZ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION; HOWEVER, TERUMO IS STILL INVESTIGATING THIS ISSUE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO 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 PRIME, THE CONNECTION IN THE VENOUS LINE HAD AN AIR LEAK. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UHC CUSTOM X-COATED ADULT PACK | CARDIOVASCULAR PROCEDURE KIT | OEZ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | 70151-04 | MK30 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |