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

Model Number 421630

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Perforation of Vessels (2135); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Mdr 1049092-2020-00100 / device 1 of 1.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that they had a patient with severe sepsis, multi-organ failure, obese and breathing difficulties, who experienced an intestinal bleed while the fecal management system (fms) was in use.It was reported that the patient had the device in place for "approximately twenty ¿ four (24) days for repeated diarrhea" during that time it was reported that he had to "sit up all the time" due to being obese and issues with breathing.According to the complainant the patient developed "severe bleeding from the intestines which required surgical intervention".The surgical procedure performed was "suturing of vessels in the anal canal x 2".The patient did require a "total blood transfusion" consisting of ¿25 (twenty-five) bags of blood, 10 (ten) plasma, and approximately 5 (five) platelets".The facility did not provide any information even though requested regarding the patient's medications and previous gastrointestinal issues besides "fragments".It should be noted that it was reported that the device had to be reinserted two separate times due to leakage and being "knocked out" and at no time was it reported/documented that a rectal exam was performed prior to insertion of the device.

• Brand Name: FMS PROTECT
• 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 ; 3365424681
• MDR Report Key: 9831148
• MDR Text Key: 191291573
• Report Number: 1049092-2020-00100
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K162906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2020
• 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