CLEARLINK
Received Jun 28, 2024 · Event occurred May 24, 2024
Report 1416980-2024-03287 · MDR key 19634402
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
NI
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. DURING A BLOOD INFUSION, IT WAS NOTICED THAT THE SET TUBING WAS LEAKING, AND A SMALL AMOUNT OF BLOOD WAS FOUND ON THE FLOOR. 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.