FDA Adverse Event
Death
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 2470577
·
Received February 24, 2012
Report
- Report Number
- 1124841-2012-00006
- Event Type
- Death
- Date Received
- February 24, 2012
- Date of Event
- December 22, 2011
- Report Date
- February 3, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- OEZ
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U REPORT 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 THE TUBING BECAME KINKED CREATING AN AIRLOCK AND THAT THE PT HAD EXPIRED. TERUMO HAS ATTEMPTED 7 PLUS TIMES TO OBTAIN ADD'L INFO ABOUT THE EVENT WITHOUT SUCCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOVASCULAR PROCEDURE KIT | CARDIOVASCULAR PROCEDURE KIT | OEZ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |