MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	772055
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 2017-06-27.
Event or Problem Description
The customer reported that while in use with a patient, the nurse clamped the tubing and the medicine was pushed through the side port when the nurse heard pop noise in the pump.The customer found that the flexible portion of the feeding tube had detached and started leaking formula.No patient injury or harm reported.
Additional Manufacturer Narrative
The device history record review of the reported lot number, shows evidence that the product was released according to all established procedures and quality assurance.One used sample was received and evaluated.The sample received shows a detachment between the silicon tube and the mystic connector (black ring).A functional test was performed.The silicon tube was reconnected to the mystic and was placed in the pump.No detachment was observed and the failure mode could not be duplicated.The possible root cause for the detachment could be related to stretching the tubing before use or incorrect placement in the pump causing additional stress to the tubing and detachment.Since the failure mode could not been duplicated the failure mode reported is not confirmed as manufacturing related and no corrective actions will apply.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6670048
• Report Number: 1282497-2017-05191
• Device Sequence Number: 11202720
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 11/13/2017

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: 772055
• Device Catalogue Number: 772055
• Device Lot Number: 162320357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1