FDA Adverse Event
Malfunction
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 1733685
·
Received June 15, 2010
Report
- Report Number
- 1212122-2010-00025
- Event Type
- Malfunction
- Date Received
- June 15, 2010
- Date of Event
- May 20, 2010
- Report Date
- May 21, 2010
- 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO DID RECEIVE THE ACTUAL DEVICE FOR EVAL. THE FOREIGN MATTER HAD DISSOLVED UPON RECEIPT, TERUMO COULD NOT IDENTIFY THE FOREIGN MATTER. THE INCORRECT PACK AND LOT NUMBER WERE REPORTED, THUS TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE CORRECT INFO IS RECEIVED. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, THEY FOUND A WHITE PIECE OF FOREIGN MATTER IN THE CARDIOPLEGIA ADMINISTRATION LINE. THE PRODUCT WAS CHANGED OUT, THERE WAS NO BLOOD LOSS AND 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |