NI
Received Aug 22, 2025
Report 1416980-2025-04311 · MDR key 22874695
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Protective Measures Problem
- Protective Measures Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS DISCARDED 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 DURING USE OF AN UNSPECIFIED BLOOD SET, AN AIR IN LINE ALARM OCCURRED ON SEVERAL NOVUM IQ LARGE VOLUME PUMPS. THE NURSE PRIMED A BLOOD SET WITH SALINE AND THEN BLOOD. AS SOON AS THE PUMP WAS PROGRAMMED, THE PUMP DISPLAYED AIR IN LINE. THE NURSE OPENED THE DOOR AND REMOVED THE SET TO VISUALIZE AIR; HOWEVER, THERE WAS NO AIR IN LINE. THE NURSE THEN RE-LOADED THE SET (MOVING BY 0.5 INCHES DOWNSTREAM), BUT THE PUMP WOULD NOT INFUSE. THIS SET WAS RELOADED ON TWO (2) ADDITIONAL PUMPS; HOWEVER, THE SAME EVENT OCCURRED. INFUSION WAS STARTED USING A NEW PRIMED SET ON ANOTHER PUMP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.