UNK CAPIOX ARTERIAL FILTER
Received Apr 8, 2019 · Event occurred Mar 13, 2019
Report 9681834-2019-00049 · MDR key 8491341
Device
Generic name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Manufacturer
Terumo Corporation, AshitakaModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G4: 510(K): K943917 THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION PRODUCT CODE/LOT NUMBER COMBINATION WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE KEY OF THE TRACKS THAT COMES WITH THE CAPIOX ARTERIAL FILTER PRESENTS LEAKS. THE ACTUAL SAMPLE WAS CHANGED OUT. THERE WAS NO IMMEDIATE PATIENT IMPACT. THE PROCEDURE OUTCOME AND FINAL PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.