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

Model Number	773656
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tubing was upside down and comes out backward.Per med watch report received from the customer on (b)(6) 2023, a defective enteral feeding tubing set was found during setup for patient use.The original intended procedure was enteral feeding.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 the 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.There was no injury reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 29-mar-2022.There was no physical sample received for the investigation; however, a picture was provided for the analysis.The provided picture was reviewed and determined that the reported model is a unidirectional model.Upon reviewing with engineering and during a brainstorming session it was concluded that the possible issue the customer is referring to is that the subassembly could be assembled incorrectly.An attempt to replicate the reported issue was performed and the reported issue was confirmed.A revision of the entire process was performed, and it was concluded that the reported issue could be related to the incorrect assembly fixtures or avoid usage of the assembly fixtures by the operator.A quality alert has been created, and staff were notified about the reported issue.An order related to a better identification of the fixtures, adding colors to identify the necessary fixture for the corresponding set, with the purpose of improving the manufacturing process has been created.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP 1000ML PUMP SET
• Common Device Name: 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: 17785770
• Report Number: 9612030-2023-03831
• Device Sequence Number: 6876812
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Device Lot Number: 2208112864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female