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

Model Number	773656
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported air bubbles in the enteral feeding line located after the black rotor on the e-pump.No patient injury was reported.
Additional Manufacturer Narrative
This follow up report is being submitted to correct the medical device problem code in section h6 from 1250 to 2964 to properly align with what the initial reporter stated.
Additional Manufacturer Narrative
Investigation summary: the customer reported air bubbles in the enteral feeding line located after the black rotor on the epump.No patient injury was reported.A device history record review was unable to be performed as the lot number reported was unknown.One used sample was received for evaluation.Visual inspection and functional testing performed confirmed the reported complaint of air in the line.An investigation has been initiated to determine the root cause of this device failure.The root cause and conclusion of the confirmed device failure will be documented within the investigation.This product issue will continue to be monitored and trended.

• Brand Name: EPUMP 1000ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10939444
• Report Number: 1282497-2020-09759
• Device Sequence Number: 3368991
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2021

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
• Operator of Device: No Information
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 11/30/2020; 11/30/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/07/2020; 02/10/2021
• Patient Sequence Number: 1