MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY NPWT SVED THERAPY DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	6701132
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported the back of the wound vac was melting while in use with a resident.There is no injury reported and the device never lost its ability to suction.The resident has a long-standing infection in her knee after a partial replacement with subsequent visits for drainage of the knee.No patient demographics were provided when requested.
Additional Manufacturer Narrative
A supplemental report is being filed since the results of investigation are now available.The device was received and upon visual inspection it was confirmed the bottom cover of the device melted due to pump overheated and the motor did not work due to damage.Root cause was pump failure due damage and off centered shaft.Capa was opened and an investigation into the overheating complaints was conducted.The following corrective actions were identified to address the root causes identified in the capa.These corrective actions are planned to be completed by (b)(6) 2021.Instructions for use (ifu) for sved device to be updated to include the warning for overheating and no direct contact of the device with patient.Update the service procedure to consider changing the motor if the motor has serviced more than 2000 hours.Implement the service timer recording in the service procedure and forms to determine when to change the motor once the serviceable life has been exhausted.Install relay cut off mechanism at appropriate threshold temperature that will cut off the current to the motor in cases when motor may draw excessive current leading to overheating effect.Cardinal health will continue to monitor the trend of this type of incident.
Event or Problem Description
The back of the wound vac was melting while in use with a resident.There is no injury reported and the device never lost its ability to suction.The resident has a long-standing infection in her knee after a partial replacement with subsequent visits for drainage of the knee.No patient demographics were provided when requested.

• Brand Name: NPWT SVED THERAPY DEVICE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 14201 nw 60th ave.; miami lakes FL
• MDR Report Key: 11574791
• Report Number: 1423537-2021-00615
• Device Sequence Number: 3124987
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 15120
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other