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

Model Number 418000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Septic Shock (2068); Tachycardia (2095); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Mdr 1049092-2020-00139 / device 1 of 1.Date of death - (b)(6) 2020.Date of event: (b)(6) 2020.Report source: ufi / importer report # (b)(4) via united states department of health and human services (fda).(b)(6).Based on the available information, this event is deemed to be a serious injury.The territory manager hosted fecal management system (fms) in-services from september 9th through september 13th, 2019, then returned on october 22nd and october 23rd.The territory manager was in the process of converting this account to the flexi-seal protect fms.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.Additional patient/event details have been requested but, to date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fms warnings: patients should be monitored daily for and a physician notified immediately if any of the following occur: rectal pain.Rectal bleeding.Abdominal symptoms such as distension/pain.Over inflation of the retention balloon has the potential to increase the risk of adverse events.Precautions and observations: care should be exercised in using this device in patients who have a tendency to bleed from either anti-coagulant / antiplatelet therapy or underlying disease.If signs of rectal bleeding occur, remove the device.Immediately and notify a physician.Preparation of patient: position the patient in left side lying position; if unable to tolerate, position the patient so access to the rectum is possible.Remove any in-dwelling or anal device prior to insertion of the flexi-seal¿ signal¿ device.Perform a digital rectal exam to evaluate suitability for insertion of device.The complainant reported that the product used was flexi-seal signal fms rx zeolite, but was unable to provide product lot information.

Event Description

It was reported that "(b)(6)-year-old patient transferred to facility on for further management of bullous pemphigoid and hematochezia.Gastrointestinal (gi) consult was following patient.A rectal tube system was inserted and five days later, in the late evening, the patient had frank blood per rectum/tube, hypotension, tachycardia and hemoglobin (hb) drop to 6.2.Patient resuscitated with massive transfusion protocol (mtp) and transferred to intensive care unit (icu) where rectal tube removed.Computerized tomography angiography (cta) revealed arterial bleed in lower sigmoidoscopy revealed erosion and clipped lesion x3 and episclerosed.Patient expired eleven days after developing septic shock (skin sources and/or aspiration pneumonia).The user facility notes "we have had several incidents where the balloon was over inflated".Multiple attempts were made to contact the user facility to obtain further details of the incident with no return call received.No lot number was provided by the complainant.No photographs received depicting the reported complaint or harm.

• 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: 10160175
• MDR Text Key: 200991854
• Report Number: 1049092-2020-00139
• 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,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model 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: 05/18/2020
• 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: 79