BLOOD RECIPIENT SET
Received Nov 25, 2024 · Event occurred Oct 10, 2024
Report 1416980-2024-06777 · MDR key 20774379
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
JC7751Catalog number
JC7751
Lot number
NI
Product problems
- Fluid/Blood Leak
- Detachment of Device or Device Component
- Fluid/Blood Leak
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H6, H11. H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLN SET WITH STANDARD BLOOD FILTER LEAKED FROM THE TUBING. THE SPIKE WAS STILL IN THE BLOOD BAG, AND THE TUBING BROKE OR POPPED OUT. THIS OCCURRED WHEN THE PUMP WAS TURNED ON TO PRIME THE LINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.