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

Model Number 6701132

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2020

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

Customer had reported that the treatment nurse had noted the negative pressure wound therapy sved therapy device 6701132 was beeping and had a burning smell.Nurse attempted to pick up device from the patient¿s foot rest (it was upright, free to air, nothing was against it) but when she grabbed it, the severe heat caused her reflexes to drop it immediately, before causing any thermal injury to herself.She then turned the vac off and assessed the device and noted that the backside of the unit, vertically, was a softened darkened area from the heat.There was no injury.Cardinal health is filing an mdr for malfunction.

Manufacturer Narrative

Supplemental report is being filed since the results of investigation are available.A sample was returned for evaluation and the investigation confirmed the pump overheated and melted the back plate of the enclosure.The device failed the cosmetic defect test (visual inspection), however, all other tests passed.These tests include vacuum test on all 3 pressure settings and a battery life test.This device ran for over 15 hours on battery life.A review of the product history review for serial number (b)(6) showed that the device was released from qa to stock on 03/08/2019.No service reports were available at the time of this review, the job router was reviewed without issue and the device passed all tests.Although the sample was received and the complaint was confirmed, the root cause could not be determined.A corrective and preventive action has been opened to further investigate the root cause of the overheating odor malfunction for the npwt sved device.We will continue to monitor for this type of incident.

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: 9945871
• MDR Text Key: 202562281
• Report Number: 1423537-2020-00450
• 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,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: Health Professional
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: FA53084
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 03/10/2020
• Supplement Dates FDA Received: 08/17/2020; 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other