inforMED
DeathFIR

BLOOD MONITOR PUMP

Received Mar 19, 2002 · Event occurred Mar 1, 2002

Report 384303 · MDR key 384303

Device

Generic name

Hemofiltration Unit

Model number

BM11A

Catalog number

*

Lot number

*

Product problems

  • Alarm, audible
  • Calibration Error
  • Failure, intermittent
  • Occlusion Within Device
  • Repair
  • Transducer failure

Patient

78 YR

  • Cyanosis
  • Death

Narrative

Description of Event or Problem

PT ADMITTED IN 2002 FOR ALTERED MENTAL STATUS AND HYPOTENSION. K+ 2.9 ON ADMISSION. NEW ONSET CYANOSIS TOES LEFT FOOT. MD ORDERED HEMOFILTRATION DUE TO PT'S CONDITION. HEMOFILTRATION UNIT ARTERIAL PRESSURE LINE ALARMING. THE NEXT DAY UNIT CHECKED. RECALIBRATED. STILL SHOWING ERROR. BAXTER SUPPORT CONTACTED. NEW TRANSDUCERS ORDERED. THE NEXT DAY REPLACED TRANSDUCERS. STILL PROBLEM WITH ARTERIAL PRESSURE. BAXTER SUPPORT CONTACTED MULTIPLE TIMES. THE NEXT DAY REPLACED TRANSDUCER PCB. ERROR STILL PRESENT. SERVICE REP IN REPORTEDLY FIXED UNIT. UNIT IN USE ON PT FOUR DAYS LATER. INTERMITTENTLY FUNCTIONING BUT CIRCUIT CLOTTING OFF. AT 0400 RESUMED HEMOFILTRATION, PT CONDITION DETERIORATED EXPIRED 0555.