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

Model Number UNKNOWN ENTERAL FEEDING

Device Problem Air/Gas in Device (4062)

Patient Problems Vomiting (2144); Weight Changes (2607)

Event Date 04/03/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: the pump bags our daughter uses with her g-tube pump have been defective.They have been causing her to gag, vomit, have abdominal pain unexplainably until now.She has been sent home from school, missed family outings and has lost weight as a result.The customer reported that they have been having problems with the enteral feeding pump.On (b)(6) 2021 cardinal health sent out a medical device correction letter regarding the kangaroo enteral feed pumping sets.The purpose of this communication was to advise customers of the potential for air appearing in the enteral feed pumping set tubing during set-up.Although there was limited information provided by the customer regarding the specific issue relating to the pump / pump set, this complaint will be filed as the reportable malfunction of air in the line with a pump set since it was in response to the communication sent out to customers regarding this issue with the kangaroo enteral feeding pump sets.

• Brand Name: UNKNOWN ENTERAL FEEDING
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12049245
• MDR Text Key: 257832473
• Report Number: 1282497-2021-10315
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN ENTERAL FEEDING
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1