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

Model Number 418000

Device Problem Device Handling Problem (3265)

Patient Problems Blood Loss (2597); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Mdr 1049092-2020-00153 / device 1 of 1.Based on the available information, this event is deemed to be a serious injury.The product was used off label per the directions for use contraindications: this product is not intended for use for more than twenty nine (29) consecutive days.Where as the device was used on the patient for twenty eight (28) days on and off and then reinserted for nine (9) more days.An in-service with the burn unit staff has been scheduled for (b)(6) 2020.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.Since there was not lot number provided, we are unable to determine the specific manufacturing site.Both potential manufacturing site numbers are listed.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 a (b)(6)-year-old male patient with "significant (40% body surface) burn injury and prolonged hospitalization complicated by lung injury / acute respiratory distress syndrome (ards) requiring tracheostomy and critical care illness".The patient received a fecal management system (fms) device for " incontinence and wound management".The device was in use from "(b)(6) 2020 through (b)(6) 2020, (b)(6) 2020 through (b)(6) 2020, (b)(6) 2020 through (b)(6) 2020, (b)(6) 2020 through (b)(6) 2020.The registered nurse (rn) noticed blood tinged stool and fms was removed." total usage of the device type was greater than that recommended in the product information for use (ifu), the patient had the device in place a total of thirty-seven (37) days.The hospital policy is to "deflate and reposition the device each shift¿, and according to the facility documentation it was noted that the retention balloon was ¿inflated 30-45, 45 was the initial volume and for the first two days then decreased to 40.The last documented inflation was 35.¿ the product was inflated within the product ifu recommendations.Due to bleeding noted from the rectum the patient was consulted by gastroenterology and had an esophagogastroduodenoscopy (egd) performed and received blood transfusions.The patient had "blood transfusions on (b)(6) 2020, related to gastrointestinal (gi) bleed.The patient received one unit of packed red blood cells (prbc) on (b)(6) 2020 and one unit of prbc on (b)(6) 2020 and two units of prbc on (b)(6) 2020.The goal was to keep the hemoglobin (hgb) above eight.A "rectal exam demonstrated profuse dark-maroon bleeding.Worsening anemia and increasing tachycardia suggest hemodynamically significant bleed.Given appearance of the bleeding and the doubling of the patient's blood urea nitrogen (bun) in the last few days, favor an upper source as most likely.Lower source, particularly rectal ulcer".According to the user facility the patient had no prior history of gi bleeding or any previous gi diagnosis.The patient was also noted with a superficial anal ulceration.

• 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 ; 3365424681
• MDR Report Key: 10222318
• MDR Text Key: 197943515
• Report Number: 1049092-2020-00153
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60