MAUDE Adverse Event Report: CARDINAL HEALTH 16FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 7771610E

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Adult Respiratory Distress Syndrome (1696); Aspiration/Inhalation (1725)

Event Date 01/11/2022

Event Type  Death  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported using device 7771610e; cardinal salem sump dual lumen stomach tube, kangaroo multifunction port w/enfit equipped device is mandatory for use as an ng tube in (b)(6) under ab444, except in emergencies.The 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 enfit salem sump 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 medications and was placed on continuous renal replacement therapy.He also was maintained on increasingly higher venditori requirements, until and nitric oxide in elation.Also, on (b)(6) he was found to be positive for covid-19 and was started on remdesivir 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 the 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.The reporter recommends the device be modified in such a way so at a single glance it is possible to tell unambiguously whether or not there is true suction being applied to the gastric lumen of the nasogastric tube.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.During manufacturing of the multi-functional port device, products are sampled and tested applying an aql 0.65 to verify the correct fluid path and to conduct leak testing.Test methods used to conduct leak and suction testing are validated methods.A review of our test procedures and calibration records revealed the test methods were performed appropriately and no changes or out of tolerance records were identified that could be associated with the reported event.Furthermore, there have been no changes or modifications to the design of this product that relate to the reported event.The device involved in this event was received for evaluation on may 19th, 2022 without its original package.The visual evaluation of the returned device consisted of verifying that the components which form the product were assembled correctly, evaluating the function of the knob to move freely and confirming there are no difficulties clearly identifying the three switch positions.In addition, a functional test was performed to evaluate for leaks, appropriate flow/fluid path, and suction performance.The results of the visual and functional evaluations revealed no non-conformances.Based on the results of the investigation, we were unable to find any evidence of product failure that could be associated with the reported event.Based on the information provided in the incident report and the evaluation of the sample returned, cardinal health believes that the multifunctional port on the salem sump was not set by clinical staff in the correct position for gastric decompression.Specifically, the incident report stated that ¿the patient was thought to be on ng suction¿, however based on the clinical presentation, it can be deduced that the patient was not receiving adequate gastric decompression via the device.The report further stated that when inspecting the multifunctional port, the switch was in the ¿intermediate position¿ and that no suction was being applied.Importantly, however, the device is not designed or intended to provide suction while the switch is in the position described in the report.The instructions for use (ifu) for this device indicates the ¿middle position¿ is a closed fluid path and is used when feeding and decompression are not needed.This position is ¿neutral¿ and is used during transport or for clamping trials as ordered by the physician.Based on this information, the multifunctional port on the salem sump was not used properly by clinical staff, and the aspiration event contributed to the patient¿s deterioration and eventual expiration.At this time, no corrective and preventive actions are needed.We will continue to monitor product field performance and reported events to further review any improvements that may be required.

• Brand Name: 16FR SALEM W/ GIENTRI PORT WIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14311576
• MDR Text Key: 290949355
• Report Number: 9612030-2022-03242
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7771610E
• Device Catalogue Number: 7771610E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White