MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NPWT CATALYST; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	68-1132
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
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
Nurse reported that the catalyst device was not providing suction.The foam dressing was not drawn down completely, and the device was not alarming.No injury was reported.No further information was provided.The event date is unknown.
Additional Manufacturer Narrative
Supplemental report is being filed following the submission of the initial mdr report that was submitted on 6/24/2022 due to the investigation findings are available.Device released from qa to stock on 10/12/2018.No service reports were available at the time of this review.Job router was reviewed without issue.Device serial #(b)(6) passed all quality control tests.A sample was received for evaluation.Device unit was inspected and tested visually and functionally and it was confirmed the root cause was due to device had a defective pump which caused no suction and lack of alarm on the device.Device to be serviced and pump to be replaced with quality control team providing management of inspection.

• Brand Name: NPWT CATALYST
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL 33578
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14808806
• Report Number: 1423537-2022-00793
• Device Sequence Number: 2382047
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 17370
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown