MAUDE Adverse Event Report: CONVATEC, PURCHASING DEPARTMENT FLEXI-SEAL SIGNAL FMS RX ZEOLITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 418000

Device Problem Inflation Problem (1310)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pneumonia (2011); Septic Shock (2068); Tachycardia (2095)

Event Date 02/16/2020

Event Type  Death  

Event Description

(b)(6) yo pt transferred to facility on for further management of bullous pemphigoid and hematochezia.Gi consult was following patient.A rectal tube system was inserted and 5 days later, in the late evening, the patient had frank blood per rectum/tube, hypotension, tachycardia and hb drop to 6.2.Patient resuscitated with mtp and transferred to icu where rectal tube removed.Cta revealed arterial bleed in lower rectum.Surgery consulted, ir consulted, rectum packed for local tamponade effect the day after insertion, sigmoidoscopy revealed erosion and clipped lesion x 3 and episclerosed.Patient expired 11 days after developing septic shock (skin sources and/or aspiration pneumonia).We have had several incidents where the balloon was over inflated.The manufacturer apparently has a new model with a visual indicator for balloon volume.

• Brand Name: FLEXI-SEAL SIGNAL FMS RX ZEOLITE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC, PURCHASING DEPARTMENT; 7900 triad center drive suite 400; greensboro NC 27409
• MDR Report Key: 9990135
• MDR Text Key: 188682356
• Report Number: 9990135
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• 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?: Yes
• Date Report Sent to FDA: 03/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 28835 DA