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

Model Number	68-1132
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Distributor returned the npwt catalyst device directly to our service center.Upon receipt at service center, device back cover was deformed due to overheating and there was an odor.Distributor was unable to provide any clinical data from it¿s end user but did state there was no known injury or adverse effect reported from the end user.
Additional Manufacturer Narrative
Supplemental report is being filed since investigation results are available following the submission of the initial mdr report submitted on (b)(6) 2021.The device was received for evaluation and tested for the issue reported.The device back cover is deformed due to overheating of the pump.No patient injury was reported.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 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 CATALYST
• Common Device Name: 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: 12432761
• Report Number: 1423537-2021-00670
• Device Sequence Number: 14381164
• Product Code: OMP
• UDI-Device Identifier: 10885380153181
• UDI-Public: 10885380153181
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 68-1132
• Device Catalogue Number: 68-1132
• Device Lot Number: 23594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown