MAUDE Adverse Event Report: CONVATEC INC FMS SIGNAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 418000

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

Patient Problems Necrosis (1971); Tissue Damage (2104)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.We are unable to determine the specific third party manufacturing site.Both potential manufacturing site numbers are listed.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported the had been admitted to the intensive care unit.A flexi seal was placed (b)(6) 2019 to profuse watery diarrhea in order to contain the effluent and divert it away from a buttock wound.The same day the patient experienced two seizures and cardiac arrest and was started on vasopressors including levophed.It is not thought that the seizures or cardiac arrest were related to use of the fecal management system (fms).The patient went into septic shock related to pre-existing urinary tract infection and had to have hemodialysis due to acute renal failure.She also experienced an upper gastrointestinal (gi) bleed related to an ulcer and a lower gi bleed but not thought to be related to the fms.On (b)(6) 2019, rectal bleeding and the necrotic prolapsed hemorrhoid was noted.A surgical consult advised to discontinue the use of the fms but, no other intervention provided.The patient continued to have watery, diffuse diarrhea until her transfer to yale for a higher level of care.The reported informed that there is no documentation of a rectal examination being performed prior to the device insertion and the device was in place for eleven days.A photograph depicting the reported complaint issue was provided by the complainant.

• Brand Name: FMS SIGNAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 8536942
• MDR Text Key: 142663179
• Report Number: 1049092-2019-00191
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 768455117178
• Combination Product (y/n): N
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MEDICATION; IMMUNOSUPPRESSIVE AND CHEMOTHERAPY MEDICATION