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

Catalog Number 66801496

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 04/17/2020

Event Type  Death  

Event Description

It was reported a patient with a foot amputation and poor arterial perfusion had a femoral-popliteal bypass graft done on (b)(6).On removal of clips, wound dehisced one-third upper thigh to half way on the lower leg.The patient went to theatre for debridement of the wound and a smith and nephew negative pressure wound therapy (npwt) was put on.The patient was discharged from the hospital on friday (b)(6) with npwt in situ and wound was improving.On (b)(6), it was reported that the device had a blockage, when the health care professional (hcp) arrived at patient¿s house the patient was pale and bleeding out.There was blood bulging in the npwt dressing and pressure bandages had to be applied to the wound.Hcp switched the machine off and disconnected the suction pipe.The canister was half filled with what appeared to be very watery blood.The blood in the suction pipe had clotted and this is what possibly raised the initial alarm of a blockage.The patient was transferred in an ambulance and died at 4 am on (b)(6) 2020 before getting to the hospital.It was noted that there is a possibility that the patient experienced an aneurysm but an autopsy was not performed.

• Brand Name: RENASYS GO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 10058989
• MDR Text Key: 191028630
• Report Number: 8043484-2020-00446
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801496
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 45 YR