MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL SALEM SUMP DUAL LUMEN STOMACH TUBE,; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 7771610E

Device Problems Inadequate Instructions for Healthcare Professional (1319); Use of Device Problem (1670); Protective Measures Problem (3015)

Patient Problems Adult Respiratory Distress Syndrome (1696); Aspiration/Inhalation (1725); Liver Damage/Dysfunction (1954); Vomiting (2144); Viral Infection (2248); Renal Impairment (4499); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Event Description

Using device (b)(4): cardinal salem sump dual lumen stomach tube, kangaroo multifunction port w/enfit 16f - this enfit equipped device is mandatory for use as an ng tube in (b)(6) under ab444, except in emergencies.This patient was severely injured in a motor vehicle collision on (b)(6) 2022, and initially went from trauma bay to the operating room for laparotomy and splenectomy and other procedures.He was admitted to the icu with traumatic brain injury and other injuries, on the ventilator and required placement of the ng tube shown above.He underwent further surgical procedures on (b)(6) 2022 and remained on the ventilator.On (b)(6) 2022 the patient bit through the pilot line of his endotracheal tube.A decision was made to perform a bronchoscopy and exchange the tube.Prior to the tube exchange, with a patient still on the ventilator, the patient was thought to be on ng suction via the kangaroo device.However during tube exchange the patient had a large amount of emesis and aspirated gastric contents into his airways.This was confirmed on the subsequent bronchoscopy.Close examination of the kangaroo device on the end fit salem some to reveal that the switch was in the intermediate position and there was actually no suction being applied to the gastric lumen.The patient subsequent course was that of continued deterioration, after the aspiration of ice he had progressive human anemic instability requirement for advance ventilation techniques, evidence of increasing acidosis liver enzyme elevation and acute kidney injury.This required by carbonate drips, increasing pest requirements, until the patient had a pa arrest on (b)(6) 2022.The patient was resuscitated after atls medication's and was placed on continuous renal replacement therapy.He also was maintained on increasingly higher venditori requirements and nitric oxide in elation.Also in (b)(6), he was found to be positive for covid-19 and we started on rim desert beer and dexamethasone, however infectious disease felt that the covid-19 was not the cause of his increasingly worse ards.The patient eventually became progressively acidotic and coagulopathic and arrested on (b)(6) 2022.The opinion of the intensivists and specialists involved in the case is that the patient died of ards after a massive gastric aspiration.Before the use of the enfit type salem sump kangaroo device nasogastric tubes, there was no ambiguity about whether or not the tube was on suction if the tubing was connected to a suction port.However with the kangaroo device, there are three switch positions, of which only one provides ng suction.While the enfit devices were designed to meet iso standards to ensure that inadvertent misconnection to non-enteral feeding devices cannot occur under adverse, stressful or low light or typical patient conditions, this device does not meet that same level of safety for ensuring that there is positive connection of suction to the ng lumen.This creates a dangerous situation in which suction may be connected to the kangaroo device, but suction is not reaching the patient, and the patient's stomach is not being aspirated.This can lead to massive aspiration which in this case was lethal.I recommend the device be modified in such a way so at a single glance it possible to tell unambiguously whether or not there is true suction being applied to the gastric lumen of the nasogastric tube.Fda safety report id # (b)(4).

• Brand Name: CARDINAL SALEM SUMP DUAL LUMEN STOMACH TUBE,
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 14074211
• MDR Text Key: 289068025
• Report Number: MW5108854
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7771610E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White