MalfunctionOMP
PREVENA¿ PEEL PLACE¿
Received Jan 29, 2026 · Event occurred Dec 2, 2025
Report 24214611 · MDR key 24214611
Device
Generic name
Negative Pressure Wound Therapy Powered Suction Pump
Manufacturer
Kci Usa, Inc.Model number
PRE1001USCatalog number
PRE1001US
Lot number
C21716V005
Patient
81 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING A CORONARY ARTERY BYPASS GRAFT (ON PUMP), THE PREVENA SPONGE WAS PLACED ON THE PATIENT, AND THE DEVICE FAILED TO MAINTAIN SUCTION. A SWITCH WAS MADE TO ANOTHER LARGE WOUND VAC MACHINE AND SPONGE SUCTION BECAME STEADY. NO HARM TO PATIENT, PREVENA DEVICE WAS GIVEN TO COORDINATOR AFTER THE CASE TO WORK WITH VENDOR REGARDING SUCTION CONCERN.