inforMED
OtherFII

FRESENIUS 2008 K

Received Dec 8, 2008 · Event occurred Nov 21, 2008

Report 2479436 · MDR key 2479436

Device

Generic name

Hemodialysis Machine

Model number

2008K

Catalog number

NA

Lot number

NA

Product problems

  • Break
  • Fluid/Blood Leak

Patient

52 YR

  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

APPROXIMATELY 1420 PM, CHARGE NURSE SUMMONED TO PATIENT'S MACHINE BY PCT, BLOOD NOTED ON THE FLOOR, ARTERIAL LINE HANGING DOWN WITH PUMP SEGMENT OUT FROM AROUND BLOOD PUMP, BLOOD LEAKING FROM ARTERIAL LINE JUST POST OF THE BLOOD PUMP SEGMENT ON LINE, PCT HAD TURNED PUMP OFF, THE ARTERIAL LINE GUIDE WAS BROKE OFF. ARTERIAL BLOOD RETURNED, UNABLE TO RETURN VENOUS. H AND H DRAWN, EXTRA 250CC SALINE GIVEN. PATIENT WITHOUT COMPLIANT OF CHEST PAIN. NO SHORTNESS OF BREATH BP 103/59, TX DC'D, DOCTOR (B)(6) NOTIFIED. HCT 34.23 HGB = 11.2. HAD PATIENT REMAINED IN THE UNIT FOR OBSERVATION 30-45 MINUTES. PATIENT REASSESSED SITTING B/P 104/54 STANDING BP 114/62. PATIENT DISCHARGED FROM UNIT AMBULATORY WITH NO COMPLAINTS. PATIENT WAS INSTRUCTED SHOULD ANY SYMPTOMS OF CHEST PAIN SHORTNESS OF BREATH TO GO TO THE EMERGENCY ROOM, PATIENT VOICED UNDERSTANDING.