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); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 01/24/2020

Event Type  Injury  

Event Description

At noon, the patient was noted to have some stool in his rectal tube, as well as some leaking around it.The bedside nurses and the pca turned the patient, cleaned him, preformed wound care to his back, and flushed the rectal tube as well as deflated it to reposition the tube.There was a total of 95cc in the balloon keeping the rectal tube in place.On the balloon port it is noted that only <45cc is meant to be instilled.The patient then began profusely bleeding from his rectum into the bed.Heparin was immediately turned off (on originally for ecmo) and safely brought to ir after an mtp was completed and he was resuscitated.A total of 6l bright red blood was suctioned out of the bed.Icu and ct surg at bedside.The rectal tube was not ever replaced.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: 9990151
• MDR Text Key: 188682419
• Report Number: 9990151
• 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): Life Threatening; Required Intervention
• Patient Age: 19710 DA