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	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record revealed the item was released to stock on 03/21/2020.Job router was reviewed and no issues were discovered.Work and serial order numbers revealed the device passed all tests.The actual complaint sample was not returned to cardinal health for investigation.Root cause for the reported condition cannot be identify.No actions identified, since no evidence of a manufacturing issue was found.We will continue to monitor trends and utilize the information as part of continuous improvement.
Event or Problem Description
A nurse called saying that the pressure setting lights are not lit up on their catalyst device.When she tried to change the pressure settings, no lights would come on to indicate which pressure setting was in use.She also said that the alarm lights may not be working, because when another nurse came to check on the patient, the dressing was puffed up and no low pressure/leak alarm was going off.The patient was placed on a wet-to-dry dressing while they wait for another device.The customer reported the actual complaint sample was available for investigation, but did not use the prepaid (b)(6) return label that was sent.No additional information or patient demographics provided.

• 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
• MDR Report Key: 12465281
• Report Number: 1423537-2021-00672
• Device Sequence Number: 4067389
• Product Code: OMP
• UDI-Device Identifier: 10885380153181
• UDI-Public: 10885380153181
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 68-1132
• Device Catalogue Number: 68-1132
• Device Lot Number: 23925
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1