MAUDE Adverse Event Report: KCI USA, INC. PROVENA PLUS 125; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 60300EP

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

On post-op day 3, the nurse noted that the wound vacuum device had a leak alarm.Dressing was noted to be intact.The nurse was unable to troubleshoot the alarm and consulted additional staff for assistance, including the wound nurse.Pump portion of the device exchanged for a new pump, adequate suction restored, no additional alarms.Patient discharged in stable condition later the same day.Fda safety report id# (b)(4).

• Brand Name: PROVENA PLUS 125
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; san antonio TX 78249 2248
• MDR Report Key: 14345736
• MDR Text Key: 291383017
• Report Number: MW5109604
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60300EP
• Device Lot Number: 9274888
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 180 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American