FDA Adverse Event
Malfunction
Summary report: N
CAPIOX AF200X ARTERIAL BLOOD FILTERS
MDR report key: 2241058
·
Received August 17, 2011
Report
- Report Number
- 1124841-2011-00353
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 29, 2011
- Report Date
- July 29, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- FGE
- PMA / PMN Number
- K022026
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO CARDIOVASCULAR SYSTEMS DID RECEIVE THE ACTUAL DEVICE FOR EVAL AND VISUAL INSPECTION CONFIRMED THE COMPLAINT. A REP RETENTION SAMPLE WAS ALSO EVALUATED AND NO FOREIGN MATTER WAS VISUALLY DETECTED. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MGMT FOR APPROPRIATE TRACKING, TRENDING AND F/U.
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THEY NOTED A SMALL HAIR INSIDE THE ARTERIAL FILTER. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPIOX AF200X ARTERIAL BLOOD FILTERS | BLOOD FILTERS | FGE | TERUMO CARDIOVASCULAR SYSTEMS CORP. | NA | ND22 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |