MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - RFB; PUMP, INFUSION, ENTERAL

Model Number 382401

Device Problem Device Alarm System (1012)

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

Event Type  malfunction  

Manufacturer Narrative

This complaint was originally reported on (b)(6) 2017 to medtronic and logged in the complaint handling system as (b)(4).The initial fda report number 3008361498-2017-05027 was submitted on 8-mar-2017.Follow up report 1 was sent on 9-mar-2017.Follow up report 2 was sent on 20-oct-2017.The fda contacted cardinal health requesting electronic resubmission of the initial fda report.This report was generated to complete the fda's request.Investigation summary: an evaluation of the kangaroo pump was performed for the reported condition of no alarm tone.The unit was triaged and the reported condition was confirmed.A trend has been identified and a capa has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.

Event Description

The customer reports the unit has no alarm tone during testing.No patient involved.

Manufacturer Narrative

This complaint was originally reported on february 23, 2017 to medtronic and logged in the complaint handling system as 701685789.The initial fda report number 3008361498-2017-05027 was submitted on 8-mar-2017.Follow up report 1 was sent on 9-mar-2017.Follow up report 2 was sent on 20-oct-2017.The fda contacted cardinal health requesting electronic resubmission of the follow up-1 fda report.This report was generated to complete the fda's request.Submit date: 3/9/2017.Follow-up to correct section b5, d4 and h6 based on additional information received.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports the unit has no alarm tone during testing.No patient involved.

Manufacturer Narrative

This complaint was originally reported on february 23, 2017 to medtronic and logged in the complaint handling system as 701685789.The initial fda report number 3008361498-2017-05027 was submitted on 8-mar-2017.Follow up report 1 was sent on 9-mar-2017.Follow up report 2 was sent on 20-oct-2017.The fda contacted cardinal health requesting electronic resubmission of the follow up-2 fda report.This report was generated to complete the fda's request.Please note: the original report was submitted with h6 investigation findings 1023 none and h6 investigation conclusions 63 device repaired and returned however these codes have since been retired therefore appropriate term/code not available was selected.An evaluation of the kangaroo pump was performed for the reported condition of no alarm tone.The unit was triaged and the reported condition was confirmed.A trend has been identified and a capa has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO EPUMP - RFB
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDEIN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 11445803
• MDR Text Key: 246713593
• Report Number: 1282497-2021-09956
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 382401
• Device Catalogue Number: 382401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1