BLOOD RECIPIENT SET
Received May 10, 2024
Report 1416980-2024-02229 · MDR key 19290956
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
JC7751
Lot number
DR24A12031
Product problems
- Backflow
- Backflow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS BACKFLOW OF SOLUTION THROUGH AN UNSPECIFIED QUANTITY OF Y-TYPE BLOOD/SOLN SETS. THIS OCCURRED DURING PATIENT INFUSIONS. THE SETS WAS PRIMED WITH NORMAL SALINE (NS) AND NS LINE WAS CLAMPED. PACKED RED BLOOD CELLS (PRBC) WERE RUNNING AND THE NS BACK-FILLED INTO THE BLOOD PRODUCT BAG. THE NS BAG WAS EMPTY AS A RESULT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
B3/D10 DATE: THE EVENTS OCCURRED ON UNSPECIFIED DATES OF MARCH AND APRIL 2024. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.