MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number UNKNOWN

Device Problems Device Alarm System (1012); Complete Blockage (1094)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

It was reported that during treatment of an infected cesarean wound in the lower abdomen of a patient with a renasys device, the blockage alarm was activated several times and each time the dressing had to be changed to continue treatment.A delay greater than 30min was reported.No patient harm reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information was received that identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: RENASYS
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10727249
• MDR Text Key: 212752752
• Report Number: 8043484-2020-03276
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 07/19/2021
• Patient Sequence Number: 1
• Treatment: 66800794, 66800795, 66800796; 66800794, 66800795, 66800796
• Patient Age: 32 YR
• Patient Weight: 80