MAUDE Adverse Event Report: SENTEC AG MULTI-SITE ATTACHMENT RING FOR MATURE/INTACT SKIN; MULTI-SITE ATTACHMENT RING EASY FOR MATURE/INTACT SKIN

Model Number	MARE-MI
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	10/26/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Alleged serious injury on extremely premature patient with translucent and fragile skin.The mare-mi was used previously on the site at which the adverse event occurred.Inconclusive which role the mare-mi had in the injury.Sentec offers another product specifically designed for use on sensitive and fragile skin (multisite attachment ring for fragile/sensitive skin mare-sf) that would have been more appropriate for use.The institution switched to use of the mare-sf after the event.The institutional practice is to keep the attachment rings on the same site as long as possible to minimize potential skin trauma from ring removal and attachment.Per our ifu - "do not use sensor attachment accessories or contact gel on injured skin or on patients who exhibit allergic reactions to these disposables" also, "we recommend leaving the site free of adhesive for up to 8 to 12 hours" and site inspection and cleaning of skin" after measurement.The severity of apparent injury may have been prevented with proper inspection and treatment.The patient condition (and environmental conditions) may have played a role in the further development of the injury.After review of all information available, including pictures of the injury site, sentec believes that the device functioned properly but because of the time on patient, patient skin condition and the (potential) effects of environmental conditions such as elevated temperature, removal of the adhesive ring irritated and/or injured the skin that may or may not have been treated immediately until consultation for wound assessment more than 2 days later.
Event or Problem Description
On (b)(6) 2021, nursing observed a neonate with infected wound, which developed a deep abdominal wall necrosis on the right abdomen.Sentec was informed 10-nov-2021, received incomplete information until 29-nov-2021.Sentec was notified of death 06-dec-2021.Neonate with infected wound, which developed a deep abdominal wall necrosis on the right abdomen.The neonate was born at the gestational age of (b)(6) and was (b)(6) old at the time of the event.The patient was extremely premature and at high risk.The patient had very translucent and fragile skin.From the description of the event and the attached pictures provided to the manufacturer, it is not conclusive as to what caused the wound.The following information was provided by the customer: the patient was under high-humidity and being hydrated on (b)(6) 2021.The measurement site on the right abdomen was used for the last time on (b)(6) 2021.After (b)(6) 2021, the sensor was placed on other body locations on the left abdomen and thighs.Nurses did not document any concern on that date and skin color was charted as normal on the prior day.No pressure or additional tape was used.The care team had changed their care for the patient and started to "dry-out" the patient.Clinical team decided to keep the mare-mi on at the same site for as long as possible, so as not to damage the skin by tearing off the ring frequently.Clinical team also noted a "burn" from pulse oximeter put on left toe (not a sentec device).Nursing noted circular breakdown on (b)(6) 2021, and placed consult for wound assessment the same day.The institution transferred the patient for higher level care to another facility.They were informed that the patient became infected with a rare fungal infection and became septic.The patient was subsequently placed on comfort care and expired on (b)(6) 2021.

• Brand Name: MULTI-SITE ATTACHMENT RING FOR MATURE/INTACT SKIN
• Common Device Name: MULTI-SITE ATTACHMENT RING EASY FOR MATURE/INTACT SKIN
• Manufacturer (Section D): SENTEC AG; ringstrasse 39; therwil, 4106 ; SZ 4106
• Manufacturer (Section G): SENTEC AG; ringstrasse 39; therwil, 4106 ; SZ 4106
• Manufacturer Contact: robert cormier ; 40 albion road; suite 100; lincoln, RI 02865 ; 8774258746
• MDR Report Key: 13083569
• Report Number: 3004149774-2021-00001
• Device Sequence Number: 17504651
• Product Code: LKD
• UDI-Device Identifier: 07640121880797
• UDI-Public: 07640121880797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: MARE-MI
• Device Catalogue Number: MARE-MI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention; Hospitalization
• Patient Age: 2 WK
• Patient Sex: Female