MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL

Model Number 775100

Device Problem Air/Gas in Device (4062)

Patient Problems Hypoglycemia (1912); Nausea (1970); Abdominal Distention (2601)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reported that a letter was received stating that the pump sets may cause excessive air entry into the feed lines and can lead to certain health consequences including vomiting, dehydration, hypoglycemia, abdominal pain and abdominal distention in patients.In this case, the patient a minor child, has experienced vomiting, dehydration, hypoglycemia, abdominal pain and abdominal distention and has been to her gi doctors for all the above over the last several months.Tests have been done to include blood work and even reducing her feed rate and even discontinued her feed to the above issues.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• 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: 11973864
• MDR Text Key: 255393663
• Report Number: 1282497-2021-10243
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: 10884521155817
• Combination Product (y/n): N
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 202580052
• 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