NI
Received Apr 14, 2025
Report 1416980-2025-02125 · MDR key 21835774
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- No Flow
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: E3, G2 (ADD SOURCE), H6 (UPDATE CODES), H11. CORRECTION: E1 (INCLUDING UPDATING E1: INITIAL REPORTER PHONE NO. TO NI). 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 IDENTIFIER (UDI) #: THE UDI COULD NOT BE PROVIDED AS THE PRODUCT CODE, LOT NUMBER AND EXPIRATION DATE UDI ARE UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED BLOOD - SOLUTION SET DID NOT RUN DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.