MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY 6701132 DAILY RENTAL; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	SVEDRENT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
From job router history review, device serial number (b)(4) was released to stock on 03/06/2016.1st time serviced was 02/02/2018, service record # (b)(4).Device passed all tests conducted.2nd time serviced was 04/20/2018, service record # (b)(4).The service tech noticed a bad odor and replaced the tubing and the pump.Device passed all tests.From the investigation of returned sample device, serial number (b)(4) passed all tests and functioned as intended.No issues were found.Leak alarm test results indicate that the device alarmed within specification (3 mins +/- 30 secs).Vacuum test results indicate that the device pressure settings are also within specification (-70mmhg +/- 7.47, -120mmhg +/- 11.21, and -150mmhg +/- 14.95).Device stabilized as intended and provided pressure on each setting selected.From the investigation, there is no abnormal situation that happened in production.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported that since the foam dressing was not suctioned down to the sacral wound and the dressing was very wet, the nurse had to remove the dressing completely and place it aside.The svedrent negative pressure wound therapy device continued to run even though the dressing was off patient and it took quite a while for the device to alarm.A new device was then applied.Debridement of wound was required.
Additional Manufacturer Narrative
Mdr supplemental report being filed due to the aware date on g4 on the initial report was entered incorrectly.The correct aware date is now being submitted.No other changes to the report are required.

• Brand Name: 6701132 DAILY RENTAL
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 14201 nw 60th ave.; miami lakes FL 33014
• MDR Report Key: 10058208
• Report Number: 1423537-2020-00458
• Device Sequence Number: 2835051
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: SVEDRENT
• Device Catalogue Number: SVEDRENT
• Device Lot Number: 14382
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 83