MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS F MEDIUM W/SOFT PORT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800795

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that during treatment using a renasys f medium w/soft port, when started an abnormal bleeding, it was evidenced that the patient had a hematoma and the dressing was badly implanted, the patient had to be surgically re-intervened to control bleeding.It is unknown how was the treatment completed.No other injury was reported.

Event Description

It was reported that during treatment using a renasys f medium w/soft port, the equipment did not make the respective drainage and allowed fluid to escape, it was found that the dressing they placed was with closter foam, therefore the handling was wrong, for putting the dressing that did not correspond to the equipment and additionally, polyurethane foam was not used to perform correct drainage, smith's foam was not placed on the patient at any time, thus causing the negative pressure carried out to be altered and damaging the tissue and producing bruises an abnormal bleeding, it was evidenced that the patient had a hematoma and the dressing was badly implanted, the patient had to be surgically re-intervened to control bleeding.The patient was operated on again 8 days after the initial placement of the dressing and it was determined that due to clinical issues (diabetes), bruising and necrosis, the patient required a transtibial right limb amputation.

Manufacturer Narrative

A1: patient identifier, a2: age or date of birth, a3: sex, b7: other relevant history, including preexisting medical conditions.Section h3, h6: the device was not returned for evaluation.Documentation review.Insufficient information has been provided to identify the device therefor a review of the associated manufacturing records could not be conducted.Historical complaint and escalation review has revealed no other case of this nature and no open or closed escalation actions.The "ifu" instruction for use, for the renasys-f foam and renasys-g gauze, ¿dressing kits with soft port are intended to be used in conjunction with smith & nephew negative pressure wound therapy (npwt) systems.In addition, carefully monitoring patients for signs of bleeding, which may lead to interruption in therapy and hemodynamic instability.If such symptoms are observed, immediately discontinue therapy, respond appropriately to control bleeding, and contact the treating clinician.The risk management documentation for renasys has been reviewed to assess whether the alleged failure and associated harm has been anticipated.Use of incorrect products is anticipated, (use of components that have not been authorised for use; use of incompatible accessories).Potential harms listed are maceration, local infection, delayed wound healing.The risk file will be updated to include ¿moderate bleeding¿ & ¿stage 2 pressure ulcer¿ as a foreseeable harms.Medical review.Based on the information provided in the ifu for the renasys-f foam and renasys-g gauze, substitutions from other manufacturers are not recommended.Therefore, the use of the unapproved combination as a procedural variance cannot be ruled out as a contributor or cause of the reported fluid leak/abnormal bleeding.It was reported, eight days after the initial placement of the dressing, the patient underwent a second surgery where it was determined the patient¿s clinical issues (diabetes), bruising, and necrosis, led to the patient¿s trans-tibial right limb amputation and not a mal performance of the smith and nephew¿s device.Therefore, the impact on the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant supporting documentation be provided, this case would be re-assessed.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• Brand Name: RENASYS F MEDIUM W/SOFT PORT
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17298454
• MDR Text Key: 318836088
• Report Number: 8043484-2023-00045
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K110647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 66800795
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male