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

Model Number 673656

Device Problems Obstruction of Flow (2423); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

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 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.

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
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11870205
• MDR Text Key: 252174084
• Report Number: 1282497-2021-10217
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521028166
• UDI-Public: 10884521028166
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 673656
• Device Catalogue Number: 673656
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Patient Sequence Number: 1