MAUDE Adverse Event Report: COVIDIEN EPUMP FEED AND 1000MLFLUSH SET; PUMP, INFUSION, ENTERAL

Model Number	773662
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
The customer reported that the tubing of the feeding set was leaking into the valve pocket of the pump and also on the tubing that goes around the rotor resulting in a flow error signal on the pump.There was no patient injury.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information provided by the customer on may 21, 2021.Section d4 has been updated to include the lot number that was provided by the customer on may 21, 2021.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Section b5 has been updated to include corrected information provided by the customer on may 21, 2021.
Event or Problem Description
The customer reported that the tubing from the bag of the feeding set was leaking water into the valve-pocket of the pump.Also, water was leaking out of the tubing from the bag that goes around the rotor.All of this resulted in a flow error signal.It appeared that the leaking occurs after they use the flush feature of the pump.There was no patient injury.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported that the tubing from the bag of the feeding set was leaking water into the valve-pocket of the pump.Also, water was leaking out of the tubing from the bag that goes around the rotor.All of this resulted in a flow error signal.It appeared that the leaking occurs after they use the flush feature of the pump.There was no patient injury.This report refers to product code 773662, epump dehp free 1000 ml 2 way, with lot number 201990051, manufactured on 8/23/2020.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 anf failure mode trending was reviewed and no related adverse trends were identified.One (1) used sample was returned for evaluation.Visual inspection identified food stuck in the line.Functional testing was unable to be performed due to the food stuck within the line.The reported product failures of leak and error code were unable to be confirmed.At this time, based on the investigation results presented, no further action has been deemed necessary.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11859908
• Report Number: 1282497-2021-10211
• Device Sequence Number: 16878909
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2021

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: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 201990051
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 05/05/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 05/25/2021; 10/09/2021
• Patient Sequence Number: 1