MalfunctionBRZ

NA

Received Dec 2, 2024 · Event occurred Oct 16, 2024

Report 20818419 · MDR key 20818419

Device

Generic name

Set, Blood Transfusion

Manufacturer

Baxter Healthcare Corporation

Model number

2C7627, 2C8750

Catalog number

2C7627

Lot number

UNKNOWN

Patient

NA · Prefer Not To Disclose

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

"PRODUCT ISSUE/ CONCERN- BLOOD TUBING MALFUNCTIONED. NURSES SPIKED BLOOD BAG WITH CLAMPING APPROPRIATELY AS NEEDED. BLOOD BEGAN TO COME OUT OF CLAMMED AREA AND RAPIDLY FILED LARGE CHAMBER RATHER THAN PROPERLY FLOWING. UNABLE TO OBTAIN ORIGINAL PACKAGING- HOWEVER FROM SUPPLY CLOSET IDENTIFIED PRODUCT BAXTER "Y-TYPE BLOOD/ SOLUTION SET WITH STANDARD BLOOD FILTER, 10 DROPS/MIN" PRODUCT #2C7627." MANUFACTURER RESPONSE FOR BLOOD TUBING Y-TYPE BLOOD/ SOLUTION SET WITH STANDARD BLOOD FILTER, 10 DROPS/MIN, BLOOD TUBING Y-TYPE BLOOD/ SOLUTION SET WITH STANDARD BLOOD FILTER, 10 DROPS/MIN (PER SITE REPORTER). ONGOING ISSUE. AWAITING BAXTER RGA.