MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. NPWT PRO NPWT THERAPY DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	6708888
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Sepsis (2067); Septic Shock (2068)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 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
Cardiac surgeon report stated that a patient using a negative pressure wound therapy device and has reported the patient to be in septic shock due to unit reportedly leaking.Patient was admitted to icu.
Additional Manufacturer Narrative
A supplemental report is being filed since investigation results are available following the submission of the initial mdr report submitted on 01/07/2021.At the time of the investigation, no lot number or sample was provided.Without the lot number we were unable to review the device history record to determine if any deviation took place during manufacturing process for the given product number.Without the lot number or sample the root cause for the reported concern cannot be determined.No action will be taken at this time; however, we will continue to monitor this failure mode for this product.

• Brand Name: NPWT PRO NPWT THERAPY DEVICE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• Manufacturer (Section G): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13193890
• Report Number: 1423537-2022-00715
• Device Sequence Number: 16565637
• Product Code: OMP
• UDI-Device Identifier: 10885380103520
• UDI-Public: 10885380103520
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 6708888
• Device Catalogue Number: 6708888
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 03/03/2022
• 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: Hospitalization; Other
• Patient Sex: Male