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

Model Number 6701132

Device Problems Overheating of Device (1437); Material Deformation (2976)

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

Event Date 01/14/2021

Event Type  malfunction  

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 Description

Customer reported that the back of the npwt sved therapy device got hot and then quit working.When the distributor picked it up the back of the unit was warped from the heat.Per customer, there was no injury nor disruption to the patient's therapy.They were able to replace the pump with a new one within 2 hours.

Manufacturer Narrative

Supplemental report is being filed following the submission of the initial mdr report submitted on 216/2020 due to the investigation findings are available.Device released from qa to stock on 11/13/2017.No service reports were available at the time of this review.Job router was reviewed without issue.Device passed all tests.Based on investigation, overheat malfunction was confirmed and it was determined a loose screw inside the pump prevented the pump from running.Root cause was a pump failure.Capa-ma029-01812 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 april 30, 2021.1.Ifu for sved device to be updated to include the warning for overheating and no direct contact of the device with patient.2.Update the service procedure to consider changing the motor is the motor has serviced more than 2000 hours.3.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.4.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.

• Brand Name: NPWT SVED THERAPY DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 14201 nw 60th ave.; miami lakes FL
• MDR Report Key: 11335135
• MDR Text Key: 233460242
• Report Number: 1423537-2021-00600
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 15890
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other