MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP FEED AND 1000MLFLUSH SET; PUMP, INFUSION, ENTERAL

Model Number 775100

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported they are receiving multiple errors such as downstream occlusion errors, the tubes are leaking water, and air is getting into the tubing.Per additional information provided on (b)(6) 2024, the customer stated that from the nursing reports it sounds like it was either leaking prior to priming or after priming, the tubes got air in them, and that caused the error messages.

Manufacturer Narrative

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

Manufacturer Narrative

Correction made to d4.Model and catalog numbers corrected to 775100.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 18847335
• MDR Text Key: 337464770
• Report Number: 9612030-2024-00044
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10192253009958
• UDI-Public: 10192253009958
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 2310804764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• 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