MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884702500
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 6/13/2017.
Event or Problem Description
The customer states the tubing was kinked between the bag and the patient causing the flow to be impeded and very slow.
Additional Manufacturer Narrative
Corrected information: sex.(if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
An evaluation of the kangaroo pump was performed for the reported condition of, ¿that the unit has no sound.¿ the unit was triaged and the customer¿s reported condition was confirmed.A trend has been identified and a corrective action has been opened to address this issue.A review of the device history record shows that this unit was manufactured in 2013 and was released meeting all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6638137
• Report Number: 1282497-2017-05174
• Device Sequence Number: 96119
• Product Code: KNT
• UDI-Device Identifier: 10884521002333
• UDI-Public: 10884521002333
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2018

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: Health Professional
• Device Expiration Date: 08/19/2019
• Device Model Number: 8884702500
• Device Catalogue Number: 8884702500
• Device Lot Number: 162320299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 05/17/2017; 05/17/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 09/07/2017; 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR