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); Smoking (1585)

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

Event Date 11/11/2021

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 the device was "smoking" and hot to the touch.Device disconnected from battery charger and removed from patient.Back of device shows signs of melting - likely where the battery is located.

Manufacturer Narrative

Supplemental report is being filed since investigation has been completed.Review of the device history record revealed the device was released to stock on 07/15/2020.The job router and the service records were reviewed without issues.Review of the serial number reported (15047) revealed the device passed all tests.The device was received for evaluation and tested for the issue reported "smoking, hot to the touch, and shows signs of melting.¿ temperature testing of the returned complaint pump and bench testing of aged pumps as part of the investigation revealed that the back panel temperature of a functional pump can reach between 40 and 50 degrees celsius while in operation.Temperatures measured during the testing remained within the acceptable limit of 60 degrees celsius.The device housings plastic is composed of fire-retardant material which has a 5va flammability rating at the wall thickness in the design and complies with the ul 94 standard.According to ul, 5va is the maximum flammability protection rating possible, and the key to this safety is if the device or plastic is self-extinguishing and is intended to mitigate the likelihood of a burn or fire and to reduce risk to a patient or care giver.As a result, the back panel provides significant protection against fire and the risk assessment conducted indicated that the probability of a hazardous situation leading to harm was low related to overheating.

• Brand Name: NPWT SVED THERAPY DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL
• Manufacturer (Section G): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 12957493
• MDR Text Key: 283393098
• Report Number: 1423537-2021-00696
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

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 Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 15047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1