MAUDE Adverse Event Report: COVIDIEN KANG EPUMP 1000ML PUMP ST-INTL; PUMP, INFUSION, ENTERAL

Model Number	673656
Medical Device Problem Codes	Obstruction of Flow (2423); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
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 the formula was not passing through the line and was bubbling despite priming the pump.When using another bag there was no problem.Patient injury/harm was reported as unknown.Additional information provided by the customer stated that when priming the pump and pressing run, the pump gave the error of "feeding error" after a few minutes.When checking the line, there were large bubbles and spaces where the formula was not flowing despite not being obstructed per observation.The pump was re-primed and within minutes gave the error again.
Additional Manufacturer Narrative
Correction: the customer reported the following potential/possible lot numbers: 2001670036, 2001670037, 193290046, 193290043, 193500165.Device code 2423, obstruction of flow, was absent from initial report.Section h6 has been updated accordingly.

• Brand Name: KANG EPUMP 1000ML PUMP ST-INTL
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11870205
• Report Number: 1282497-2021-10217
• Device Sequence Number: 14400233
• Product Code: LZH
• UDI-Device Identifier: 10884521028166
• UDI-Public: 10884521028166
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• 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
• Report Date (Section B): 07/22/2021

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: 673656
• Device Catalogue Number: 673656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/22/2021
• Patient Sequence Number: 1