FRESENIUS
Received May 20, 2008 · Event occurred May 12, 2008
Report MW5006977 · MDR key 1050090
Device
Product problems
- Device Alarm System
- Disconnection
- Fluid/Blood Leak
Patient
52 YR
- Therapy/non-surgical treatment/delayed/prolonged
- Treatment with medication(s)
- Hospitalization required
- Blood Loss
Narrative
Description of Event or Problem
PATIENT WAS ON HEMODIALYSIS TREATMENT AT STATION 1, MACHINE. AT 0750, PATIENT CARE TECH, DK, NOTED BLOOD ON PT'S MACHINE AND SURROUNDING FLOOR AREA. SHE IMMEDIATELY CHECKED THE MACHINE AND FOUND THAT THE VENOUS MONITORING LINE TO TRANSDUCER HAD BECOME DISCONNECTED RESULTING IN BLOOD LOSS OF APPROXIMATELY 1 LITER. PCT ALERTED NURSING STAFF WHO IMMEDIATELY ASSESSED THE PT AND ADMINISTERED SALINE AND RETURNED THE PT'S BLOOD TO HER. THE PHYSICIAN AND 911 WAS CALLED. PATIENT WAS TRANSFERRED TO THE ER VIA AMBULANCE TRANSFER AT APPROXIMATELY 0820. PATIENT LEFT WITH ACCESS NEEDLES INTACT AND SALINE INFUSING AT KOV. BLOOD PRESSURE 100/56. PATIENT WAS ALERT AND VERBAL ON DISCHARGE FROM CLINIC. PRIOR TO NOTING BLOOD LOSS AT 0750, PATIENT HAD BLOOD PRESSURE CHECKS DONE AT 0730 AND 0737 BY THE PCT AT WHICH TIMES NO BLOOD LEAKS WERE NOTED. PATIENT HAD BEEN ON TREATMENT SINCE 0655. OUTCOME: ADMITTED TO ICU FROM ER, BLOOD TRANSFUSIONS REQUIRED. NO ALARMS SOUNDED, SO STAFF WAS NOT IMMEDIATELY AWARE OF THE PROBLEM WITH THE MACHINE. STAFF NOTED THE PROBLEM WHEN THEY SAW BLOOD ON THE MACHINE AND SURROUNDING FLOOR.