BLOOD RECIPIENT SET

Additional Manufacturer Narrative

D4 UNIQUE DEVICE IDENTIFIER: AS THE LOT # IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI NUMBER ONLY. 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 BLOOD RECIPIENT SET EXHIBITED BACKFLOW OF NORMAL SALINE (NS) DURING A BLOOD TRANSFUSION. THE EVENT OCCURRED APPROXIMATELY ONE HOUR AFTER INITIATION OF THE TRANSFUSION, WHEN THE NURSE OBSERVED DURING A ROUTINE VITAL SIGNS CHECK THAT THE BLOOD BAG VOLUME APPEARED TO NOT BE DECREASING IN VOLUME. THE NORMAL SALINE LINE WAS CLAMPED AT THE Y-SITE, BUT THE BLOOD INFUSING APPEARED DILUTED IN COLOR. THE NURSE APPLIED TWO CLAMPS TO THE NORMAL SALINE LINE, AFTER WHICH THE APPEARANCE OF THE INFUSED BLOOD IMPROVED TO BE THE CORRECT COLOR. THE INFUSION RATE WAS SUBSEQUENTLY ADJUSTED TO INFUSE WITHIN 4 HOURS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.