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

Model Number 773662

Device Problem Air/Gas in Device (4062)

Patient Problems Abdominal Cramps (2543); Weight Changes (2607)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported issues with air getting into the feeding tube bag lines.She stated her son has experienced intense cramping early in the morning after feeding all night.She has also noticed extra formula that should not still be in the bag after running all night so he is not getting all of the formula that is supposed to be distributed via the ml/rate per hour.Additional information provided on 21-jun-2021 stated that the product was epump set with flush bag (anti-free flow 1000ml).The patient is a (b)(6) male with gastroparesis.They did not seek medical attention immediately, but this issue had been going on intermittently over several weeks and did result in consulting the patient's gi doctor, nutritionist and dietitian to try and figure out why this was a new symptom.The patient had begged his parent several times to not hook him up because the pain he felt was associated with the feedings.The patient lost 10+ pounds and they were contemplating changing formulas, but he had been doing fine on this special formula leaving them perplexed.On (b)(6) 2021 the initial reporter confirmed there was no treatment or medication given to the patient.They drove 10 hours round trip to get to his care team.They met with a huge team trying to come up with a collaborative reason (to no avail) as to why he was having cramping after feeds when he did not have this trouble before.They could not figure it out.So there was no treatment but they talked about the concern of him losing weight and having to closely monitor this ongoing and vent his tube (to try and release any air).

Manufacturer Narrative

Additional information h2, h3, h6 investigation conclusion the reported complaint stated air is getting into the feeding tube bag lines.Her son has experienced intense cramping early in the morning after feeding all night.She has also noticed extra formula that should not still be in the bag after running all night, so he is not getting all the formula that is supposed to be distributed via the ml/rate per hour.Additional information provided stated the patient is a 20-year-old male with gastroparesis.They did not seek medical attention immediately, but this issue had been going on intermittently over several weeks and did result in consulting the patient's gi doctor, nutritionist and dietitian to try and figure out why this was a new symptom.The patient had begged his parent several times to not hook him up because the pain he felt was associated with the feedings.The patient lost 10+ pounds and they were contemplating changing formulas, but he had been doing fine on this special formula leaving them perplexed.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 not returned for evaluation; however, photographs were provided by the customer.Examination of the photographs confirmed the reported product failure as air was identified within the tubing line.A formal investigation was initiated to determine the root cause and preventive and/or corrective actions necessary.This complaint will be used for monitoring and trending purposes.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Type of Device: 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12046481
• MDR Text Key: 258962461
• Report Number: 1282497-2021-10310
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 773662
• Device Catalogue Number: 773662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male