MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC EPUMP SET 1000ML; PUMP, INFUSION, ENTERAL

Model Number 773656

Patient Problem Insufficient Information (4580)

Event Date 07/12/2023

Event Type  malfunction  

Event Description

A defective enteral feeding tubing set was found during setup for patient use.The kangaroo pumps rotate counterclockwise drawing from the bag on the left side and delivering to the right side which attaches to the patient.Some of our tubing has the reverse orientation which results in air being pulled in from the patient side and back flowing into the bag that contains the feeding.The reference number and lot number are identical from defective set to proper set.

• Brand Name: EPUMP SET 1000ML
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17710407
• MDR Text Key: 322946132
• Report Number: 17710407
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Device Lot Number: 2208112864
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Female