SPECTRA OPTIA IDL SET
Received Mar 13, 2018 · Event occurred Feb 28, 2018
Report 7333557 · MDR key 7333557
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Catalog number
10310
Lot number
1712123230
Product problems
- Detachment Of Device Component
- Defective Device
Patient
69 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
TERUMO BCT CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC)/IDL KIT HAD A DEFECT IN THE INLET MANIFOLD, THE WELDING CAME UNDONE FOR UNKNOWN REASON. THE PATIENT DID NOT RECEIVE THEIR BLOOD BACK DUE TO THE KIT MALFUNCTION ISSUE. PATIENT WAS IMMEDIATELY DISCONNECTED AND THE ATTENDING PHYSICIAN WAS NOTIFIED OF THE EVENT. MANUFACTURER RESPONSE FOR CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) KIT, TERUMO BCT CMNC (IDL) KIT (PER SITE REPORTER): MANUFACTURER HAS NOT RESPONDED WITH THEIR FINDINGS AT THIS TIME.
Additional Manufacturer Narrative
THE FOLLOWING ELEMENTS HAVE BLANK DATA.
Description of Event or Problem
TERUMO BCT CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC)/IDL KIT HAD A DEFECT IN THE INLET MANIFOLD, THE WELDING CAME UNDONE FOR UNKNOWN REASON. THE PATIENT DID NOT RECEIVE THEIR BLOOD BACK DUE TO THE KIT MALFUNCTION ISSUE. PATIENT WAS IMMEDIATELY DISCONNECTED AND THE ATTENDING PHYSICIAN WAS NOTIFIED OF THE EVENT. MANUFACTURER RESPONSE FOR CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) KIT, TERUMO BCT CMNC (IDL) KIT (PER SITE REPORTER). MANUFACTURER HAS NOT RESPONDED WITH THEIR FINDINGS AT THIS TIME.