SC+ QBL SOFTWARE
Received Apr 15, 2025 · Event occurred Mar 27, 2025
Report 3015967359-2025-00626 · MDR key 21838682
Device
Generic name
Image Processing Device For Estimation Of External Blood Loss
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0894-000-005
Product problems
- Low Readings
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PER THE USER FACILITY, A RECENT C-SECTION CAME UP WITH ONLY 26ML OF BLOOD LOSS IN THE CANISTER. THE PATIENT HAD A TOTAL QBL 619ML BUT ONLY 26ML DISPLAYED ON THE CANISTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
UPDATE: D9, H3, H6. CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE LOG FILES WERE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem
PER THE USER FACILITY, A RECENT C-SECTION CAME UP WITH ONLY 26ML OF BLOOD LOSS IN THE CANISTER. THE PATIENT HAD A TOTAL QBL 619ML BUT ONLY 26ML DISPLAYED ON THE CANISTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.