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)
Date of Event	05/05/2021
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 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.
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
Section b5 has been updated to include additional information provided by the customer on (b)(6) 2021.Section b5 has been updated to include corrected information provided by the customer on (b)(6) 2021.Br.
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 is regarding product code 773662, epump feed and 1000mlflush set, with lot number 2100210964.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported failure.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Lot and failure mode trending was reviewed and no related adverse trends were identified.One (1) used sample was returned for evaluation.Visual inspection identified no physical damage on the feeding bags or tubings sets.Functional evaluation performed via an underwater leak test and a leak was not identified.The reported device failure was not confirmed.Additional action will not be taken at this time.Current process controls are run in accordance with product specifications to meet quality acceptance criteria.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
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11842167
• Report Number: 1282497-2021-10206
• Device Sequence Number: 4545464
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2021

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: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 2100210964
• 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: 05/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 05/05/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 05/25/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown