MAUDE Adverse Event Report: COVIDIEN 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	02/08/2021
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that they wasted five enteral feeding pump sets because air was accumulating in the tubing (between pump and patient).The air space in the tubing measured between 1 in to 1 1/4 inch.No patient injury was reported.
Additional Manufacturer Narrative
Additional information added to section e1.
Additional Manufacturer Narrative
Investigation summary: the customer reported they wasted five enteral feeding pump sets because air was accumulating in the tubing (between pump and patient).The air space in the tubing measured between 1in to 1 1/4 inch.No patient injury was reported.The report refers to product code 773656, epump dehp feed 1000 ml, with lot number 201810048.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Lot and failure mode trending was reviewed and no trend was identified.A total of eight (8) samples were received for evaluation.Visual inspection and functional testing performed confirmed the report of air in the line.An investigation has been initiated to determine the root cause of this confirmed device failure.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): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11322160
• Report Number: 1282497-2021-09909
• Device Sequence Number: 3443349
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2021

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
• Device Lot Number: 201810048
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021; 02/08/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 02/23/2021; 05/06/2021
• Patient Sequence Number: 1