PRISMA CONTROL UNIT
Received Jan 12, 2007 · Event occurred Dec 14, 2006
Report 9616240-2007-00008 · MDR key 810527
Device
Generic name
Intensive Care Hemodialysis
Manufacturer
Gambro DascoModel number
PRISMACatalog number
018080001D
Lot number
NA
Product problems
- Leak/Splash
Patient
YR
- Blood Loss
Narrative
Additional Manufacturer Narrative
NO MEDICAL INTERVENTION WAS REPORTED. QUANTITY OF BLOOD LOSS UNK. THE MACHINE WAS CHECKED BY THE SERVICE TECH. HE FOUND THERE WAS A 3-WAY STOP-COCK CONNECTOR BETWEEN THE BLOOD TUBING SET AND THE CATHETER AS A POTENTIAL SOURCE OF THE BLOOD LEAKAGE. A GAMBRO SERVICE TECH INSPECTED THE MACHINE. NO MALFUNCTION WAS FOUND. THE TECHNICIAN WAS ABLE TO SIMULATE AND DEMONSTRATE THE PROPER FUNCTION OF THE PRESSURE TRENDING LIMITS: "CAUTION: RETURN DISCONNECTION CAN NOT BE DETECTED" ALARM AND 'WARNING: RETURN DISCONNECTION ALARM". THE SECOND ALARM STOPS THE BLOOD PUMP AND CLOSES THE VENOUS CLAMP WHEN THE RETURN PRESSURE FALLS BELOW + 10 MMHG. THE PHYSICIAN COMPLAINED THAT DURING THE "CAUTION: RETURN DISCONNECTION CAN NOT BE DETECTED" ALARM A SIGNIFICANT AMOUNT OF BLOOD COULD BE LOST.
Description of Event or Problem
THE CUSTOMER REPORTED THERE WAS A LEAKAGE ON THE RETURN LINE WITH A BLOOD LOSS WITH NO ALARMS.