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	Wound Dehiscence (1154); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
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
Customer reported nurse manager had a male patient with sternal incision that dehisced, so the negative pressure wound therapy pro device was placed on this complex chest wound.When he came home, he had a lot of drainage, and was on iv antibiotics, the antibiotics ceased but they were still doing 5x visits a week because they felt the suction wasn't working properly and the patient kept experiencing issues with pooling under the dressing.The dressing had a good seal, but the pump was just not removing all the exudate.They changed the pump for a new pro device on nov 10 worried that it was a pump issue, and he did feel there was improved suction with it.Unfortunately, because of the pooling of fluid, he also had a lot of maceration by then.He also developed a fluid filled pocket at the bottom of the wound.Over the weekend (nov 13-14) the client was admitted to hospital with an infected wound site.
Additional Manufacturer Narrative
Supplemental report is being filed since investigation has been completed.Review of the device history record revealed the device was manufactured on dec 14, 2018.Further review of the record confirmed the device was inspected based on our inspection plan and no issues were detected during the inspection.One device was returned for investigation.Visual review of the returned device revealed the serial number to be (b)(6).The returned device was inspected according to our final inspection procedure and was found to be working properly.There were no issues detected during the investigation of the returned device and no malfunction was found.The device met specifications and works as per requirements.Operators participating in the manufacture of the serial number are certified in their respective processes.We will continue to monitor trends and utilize the information as part of continuous improvement.

• 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 12978298
• Report Number: 1423537-2021-00697
• Device Sequence Number: 11831720
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: C1201805611
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male