inforMED
MalfunctionKZD

MEDLINE

Received Jun 22, 2026 · Event occurred May 26, 2026

Report 1417592-2026-02920 · MDR key 25588198

Device

Generic name

Pressureplus Infusion Bag, 1000ml

Catalog number

DYNJPI1000C

Lot number

81725110003

Product problems

  • Pressure Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE BAG DOESN'T HOLD AIR.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE BAG DOESN'T HOLD AIR. THIS IS WHEN AIRED UP TO DESIRED PRESSURE AND THEN STOP COCK TURNED AS DIRECTED, THE BAG STILL LOSES AIR AND DOES NOT PROVED PRESSURE. TRIED ANOTHER CONTACTED ANOTHER UNIT TO GET ANOTHER TO USE. SWITCHED OUT WITH BP CUFF AND AIRED TO DESIRED PRESSURE. THE PRESSURE BAG WAS FAULTY SO WE HAD TO RESORT TO PUTTING A BLOOD PRESSURE CUFF ON TO PROVIDE A PRESSURE BOLUS TO THE PATIENT. THIS HAPPENED ON LOTS OF PATIENTS. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.