MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NPWT DEVICE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800164

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Sepsis (2067)

Event Date 12/11/2013

Event Type  Injury  

Event Description

Iodosorb was initially prescribed with follow up two days later.Wound was re-assessed as appropriate for npwt, applied by experienced s&n npwt practitioner.(b)(6) 2013 followed up on patient's progress, informed the wound was doing well and that npwt therapy had been discontinued because the patient could not sleep with the machine constantly ticking.Treatment switched back to iodosorb.On (b)(6) 2013 the surgical ward called to inform me that the patient was admitted to hospital with wound sepsis.During hospital visit the patient stated that the machine kept alarming and showing low battery.The next day the patient underwent surgical debridement.

Manufacturer Narrative

Smith & nephew received the above product complaint for adverse event.This complaint is considered inconclusive due to lack of information.No product was returned for evaluation and no lot number information was provided.Based on the medical history provided, it is stated the patient was post-operative coronary artery bypass with dehisced venous donor area on right leg which was initially assessed and found to have slough and was infected.Additional information suggests that lack of communication and patients¿ non-compliance with his plan of care were noted which may have directly contributed to readmission to the hospital with sepsis.It was also stated the reported complaint was more related to the service provided to patient rather than the product used.At this time, there is no reason to suspect that the device and disposable kits used failed to meet any product specifications.No further actions will be taken and this investigation could be closed.If additional relevant information is provided at a later date, the complaint could be reviewed and appropriate actions taken.The complaint is recorded and any similar issues will be monitored through the complaint system.

Event Description

Iodosorb was initially prescribed with follow up two days later.Wound was re-assessed as appropriate for npwt, applied by experienced s&n npwt practitioner.(b)(6) 2013 followed up on patient's progress, informed the wound was doing well and that npwt therapy had been discontinued because the patient could not sleep with the machine constantly ticking.Treatment switched back to iodosorb.On (b)(6) 2013 the surgical ward called to inform me that the patient was admitted to hospital with wound sepsis.During hospital visit, the patient stated that the machine kept alarming and showing low battery.The next day the patient underwent surgical debridement.

Manufacturer Narrative

Active investigation in progress; results of investigation will be provided in a supplement report.

• Brand Name: RENASYS GO NPWT DEVICE
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 3647553
• MDR Text Key: 4562624
• Report Number: 3006760724-2014-00022
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 02/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention