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

Model Number 68-8888

Device Problems No Audible Alarm (1019); Suction Failure (4039)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

Customer report indicated that the motor on the device was not running when the canister was removed, however the unit still had plenty of therapy time remaining.The unit tech was unsure if the dressing was sealed and depressed while on the patient.The device was tested once it was returned to the unit¿s department.Testing confirmed that there was no suction.Unit tech was unsure if the device sound setting was changed when it was used but confirmed that the device did not alarm when they tested the unit.There was no injury to patient and patient is doing fine and is still using the backup device provided by the facility.

Manufacturer Narrative

The device with lot number c01201904740 was manufactured in 2019.The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.Based on the investigation, no specific assignable cause can be determined as there is limited information.Without a specific assignable cause, no action will be taken at this time.We will continue to monitor trends based on this type of issue.

• Brand Name: NPWT ALLY
• Type of Device: 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: 13764911
• MDR Text Key: 290447151
• Report Number: 1423537-2022-00734
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380153204
• UDI-Public: 10885380153204
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Report Date: 03/14/2022

1 Device was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 68-8888
• Device Catalogue Number: 68-8888
• Device Lot Number: C01201904740
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown