LASERFLO
Received Apr 5, 2001 · Event occurred Feb 1, 2001
Report 2183929-2001-00001 · MDR key 325977
Device
Product problems
- High Readings
Patient
UNKNOWN
- Tissue failure
Narrative
Description of Event or Problem
IN OR ABOUT 2001 THE BPM2 MONITOR WAS USED WITH ITS ACCESSORIES POSTOPERATIVELY TO MONITOR BLOOD FLOW ON A TRAM BREAST RECONSTRUCTION AT HOSPITAL. THE PT HAD VERY PALE ABDOMINAL SKIN DURING MONITORING. THE BPM2 REGISTERED BLOOD FLOW VALUES BETWEEN 0.85 AND 1.3 FLOW UNITS. THIS FLOW LEVEL RANGE IS CONSIDERED BY MOST BPM2 USERS, INCLUDING THE ATTENDING SURGEON, TO BE AT THE MARGIN BETWEEN ACCEPTABLE AND POOR, AND READINGS BELOW 1.0 GENERALLY INDICATE THE NEED FOR CLOSE SURVEILLANCE. THE TISSUE HAD A GOOD APPEARANCE FOR SOME HOURS AFTER SURGERY, BUT ON THE FOLLOWING MORNING ITS APPEARANCE WAS POOR, WHILE BLOOD FLOW READINGS REMAINED IN THE SAME RANGE AS BEFORE. SALVAGE OF THE RECONSTRUCTION WAS NOT POSSIBLE. NO OTHER COMPLICATIONS WERE REPORTED, AND THE PT HAS APPARENTLY HAD NO OTHER ADVERSE RESULTS.
Remedial action
- Inspection