MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number 772055

Device Problem Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

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.

Event Description

Customer reports: air entered into the tubing.

Manufacturer Narrative

Additional information h2, h3, h6 information conclusion the reported complaint stated air entered the tubing.There was no patient injury/harm reported.A device history record (dhr) review was not performed as the lot number reported was unknown.Failure mode trending was reviewed, and no related adverse trends were identified.The reported product was returned for evaluation.Visual inspection and functional testing performed determined the device met specification.No fault was found during the investigation; therefore, the reported product failure was not confirmed.Additional action will not be taken at this time.This complaint will be used for monitoring and trending purposes.

• Brand Name: EPUMP 500ML PUMP SET
• 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: 11991756
• MDR Text Key: 259390845
• Report Number: 1282497-2021-10274
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 772055
• Device Catalogue Number: 772055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1