FDA Adverse Event
Malfunction
Summary report: N
SPECTRA OPTIA IDL SET
MDR report key: 19972023
·
Received August 13, 2024
Report
- Report Number
- 19972023
- Event Type
- Malfunction
- Date Received
- August 13, 2024
- Date of Event
- February 21, 2024
- Report Date
- March 20, 2024
- Manufacturer
- TERUMO BCT, INC.
- Product Code
- GKT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ATTEMPTED 2 TIMES TO PRIME TUBING FOR PROCEDURE WITH THE SAME ALARM SOUNDING DURING THE PRIMING PROCESS ("RETURN LINE AIR DETECTOR FAILED FLUID CHECK"). WE CHANGED APHERESIS MACHINES AND AGAIN GOT THE SAME ALARM SOUNDING. SO FAILURE WITH 3 SEPARATE TUBINGS, ALL OF THE SAME LOT NUMBER. SUCCESSFUL WITH PRIMING THE MACHINE WITH THE 4TH TUBING USING A DIFFERENT LOT NUMBER. CONTACTED TERUMOBCT ABOUT PROBLEM AND THE REP STATED THEY HAVE SEEN AN INCREASE IN THIS ALARM. NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1683386 | SPECTRA OPTIA IDL SET | SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC | GKT | TERUMO BCT, INC. | 12320 | 2306166141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |