MAUDE Adverse Event Report: CARDINAL HEALTH; PUMP, INFUSION, ENTERAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

The customer reported a pediatric death with a patient who was receiving nocturnal continuous pump enteral feedings via ng tube.The item code and serial number of the pump were not provided.Additional information received on 25apr2023 stated that the patient was fed at night but it is unknown if the patient was bolus or pump fed.The customer confirmed there were no malfunctions with the feeding pump.The customer further stated that they have no knowledge of the autopsy to make any claims as to causation.The cause of death is not currently known.The customer stated that they have no additional information at this time.

Manufacturer Narrative

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

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation.Per the customer, there was no malfunction of the feeding pump reported.At this time, we are unable to determine the relationship between the device and reported event.Although multiple attempts have been made to retrieve additional information, the customer indicated there will be no additional details provided.The service history record (dhr) review for the serial number involved in this complaint could not be performed as the serial number was not reported.If additional information or the device is received, the investigation will be reopened and responded to accordingly.We will continue to trend this issue for future occurrences as part of the complaint review process.

Manufacturer Narrative

Section e1 name prefix/title - added "dr" as this field was inadvertently left blank on the initial report.Section h6 type of investigation - corrected from 3331 to 4118 as 3331 was selected in error on the initial report.

• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16827358
• MDR Text Key: 314132213
• Report Number: 1282497-2023-10752
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death