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

Model Number	773656
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Vomiting (2144); Abdominal Cramps (2543)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that her (b)(6) year old daughter has been experiencing nearly all of the symptoms that were listed in a letter received regarding kangaroo pump bags.She has been experiencing unexplainable vomiting, gagging, abdominal cramping and has been sent home from school 6 times as a result.The customer has changed her diet to try and remedy the problem.
Event or Problem Description
On (b)(6) 2021, cardinal health sent out a medical device correction letter regarding the kangaroo enteral feed pumping sets.The purpose of this communication was to advise customers of the potential for air appearing in the enteral feed pumping set tubing during set-up.Although there was limited information provided by the customer regarding the specific issue relating to the pump/pump set, this complaint will be filed as the reportable malfunction of air in the line with a pump set since it was in response to the communication sent out to customers regarding this issue with the kangaroo enteral feeding pump sets.
Additional Manufacturer Narrative
Additional information: b5: additional information has been added to the description summary.

• 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: 11718539
• Report Number: 1282497-2021-10105
• Device Sequence Number: 17198671
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 210250037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Patient Age: 10 YR