InjuryDWB
SARNS/3M
Received Jan 3, 1997 · Event occurred Oct 29, 1996
Report 66203 · MDR key 66203
Device
Generic name
Cardiopulmonary Bypass Roller Pur
Manufacturer
3m HealthcareModel number
SARNS 8000Catalog number
*
Lot number
*
Product problems
- Air Leak
- Delayed Alarm
- Device Alarm System
- Failure to Pump
Patient
2 MO
- Seizures
Narrative
Description of Event or Problem
THIS INFANT WENT TO THE OR ON 10/29/96 FOR A CARDIAC TRANSPLANT. WHILE THE PT WAS ON CARDIAC BYPASS, THE PUMP SUDDENLY STOPPED BUT FAILED TO ALARM OR OTHERWISE ALERT THE TECH. IMMEDIATELY AFTER REALIZING THE PUMP HAD STOPPED, THE TECH NOTED THAT THERE WAS AIR IN THE ARTERIAL LINE FROM THE AIR FILTER TO ABOUT 18 INCHES FROM THE PT. IT WAS AT THIS POINT THAT THE AIR SENSOR ALARMED. THE LINES WERE IMMEDIATELY CLAMPED AND THE AIR WAS PURGED FROM THE SYSTEM. THE PT EXHIBITED SEIZURE ACTIVITY AFTER SURGERY AND PRESENTLY HAS AN ABNORMAL EEG.