CLEARLINK BLOOD RECIPIENT SET
Received Mar 29, 2024 · Event occurred Feb 29, 2024
Report 1416980-2024-01414 · MDR key 19004111
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2C8750
Lot number
DR23L07024
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET "SNAPPED". THIS WAS OBSERVED AFTER THE PLATELET INFUSION COMPLETED; THE PLATELET SIDE OF BLOOD TUBING WAS CLAMPED AND THE SALINE SIDE WAS OPENED. THE PLATELET BAG FELL AND THE BAG WAS "WAS STILL SPIKED, AND THE TUBING HAD SNAPPED". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
H10: TWO (2) ACTUAL DEVICES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND OBSERVED THAT THE SPIKE WAS SEPARATED FROM THE TUBING FOR BOTH SAMPLES. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE RELATED TO AN ASSEMBLY ISSUE DURING MANUFACTURING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.