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

Model Number	772055
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Customer reports: air entered into the tubing.
Additional 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
• Common Device Name: 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
• Report Number: 1282497-2021-10274
• Device Sequence Number: 4187334
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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
• Device Model Number: 772055
• Device Catalogue Number: 772055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown