MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY 6701132 DAILY RENTAL; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number SVED RENT

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

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 device her patient was using got so hot it started melting the front of the device.The device was standing straight up, but the device got so hot the front started melting and has a burn spot on the front.No patient demographics were provided when requested.

Manufacturer Narrative

Supplemental report is being filed following the submission of the initial mdr report submitted on 2/20/2021 due to the investigation findings are available.Device released from qa to stock on 05/21/2019.Device was serviced on 09/03/2020 with no problem found.Job router was reviewed without issue.Device passed all tests.Complaint of overheat of device confirmed.Investigation found a loose screw inside the pump, possibly causing the pump to seize and overheat.The overheated pump melted wiring and the back of the enclosure.Suggest replacing pump wiring and back of enclosure.The root cause is 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.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 is 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.

• Brand Name: 6701132 DAILY RENTAL
• 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: 11332838
• MDR Text Key: 233722556
• Report Number: 1423537-2021-00595
• 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: health professional,user faci
• Remedial Action: Other
• 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: SVED RENT
• Device Catalogue Number: SVED RENT
• Device Lot Number: 19553
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other