CLEARLINK
Received Oct 4, 2024
Report 1416980-2024-05481 · MDR key 20374107
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
DR23J27086
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
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 DISCARDED; 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 THE TUBING OF A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET SNAPPED OFF AT THE SPIKE AND BLOOD LEAKED ON AN UNSPECIFIED PUMP. THIS WAS OBSERVED WHEN THE NURSE TURNED THE BLOOD BAG TO REVIEW THE LABEL BEFORE A BLOOD TRANSFUSION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
B3: THE EVENT OCCURRED DURING AN UNSPECIFIED DATE OF (B)(6) 2024. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.