CLEARLINK
Received Nov 11, 2024
Report 1416980-2024-06426 · MDR key 20652277
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
ASKU
Product problems
- Detachment of Device or Device Component
- 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
D4: LOT #: SUSPECTED LOTS ARE DR24D23062 OR DR24D08031. 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 DISLODGED FROM THE DRIP CHAMBER. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4: EXPIRATION DATE, H4, H6, H11. D4: EXPIRATION DATE FOR BOTH SUSPECT LOTS ARE N/A. H4: MANUFACTURING DATE FOR THE SUSPECTED LOT DR24D23062 WAS 04/24/2024 AND MANUFACTURING DATE FOR SUSPECTED LOT DR24D08031 WAS 04/09/2024. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THE SUSPECTED LOTS. 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.