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

Model Number 6701132

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2020

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

Device got hot enough to cause some melting on the device.No additional information or patient demographics were provided upon request.Cardinal health is filing a report for potential risk.

Manufacturer Narrative

During investigation the device history record (dhr) was reviewed and no issues were discovered- device passed all tests.The device was manufactured on 5/29/2013.Our investigation was limited to only the dhr review since the device was not returned for evaluation.Several attempts to obtain the device were made.

Manufacturer Narrative

Supplemental report being filed to include corrective actions identified during the investigation and capa process.Capa has been opened and an investigation into the overheating complaints was conducted.The following corrective actions were identified to address the root causes identified during the investigation: 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 as 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.These corrective actions are planned to be completed by april 30, 2021.

• 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 33014
• MDR Report Key: 10243078
• MDR Text Key: 199829562
• Report Number: 1423537-2020-00479
• 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: company representative
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2021

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
• Device Operator: No Information
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 13328
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 06/12/2020; 06/12/2020
• Supplement Dates FDA Received: 10/02/2020; 02/15/2021
• Patient Sequence Number: 1