MAUDE Adverse Event Report: COVIDIEN MFG PLAINFIELD

Model Number 482400

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 26-apr-2017.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reports that the unit fails accuracy tests.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of flow error and fails accuracy tests.The unit was triaged and the customer¿s reported condition was confirmed.A trend has been identified and a capa has been opened to address this issue.A review of the device history record shows that this unit was manufactured in 2010 and was released meeting all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6524721
• MDR Text Key: 73902019
• Report Number: 3008361498-2017-05088
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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
• Device Operator: No Information
• Device Expiration Date: 04/09/2015
• Device Model Number: 482400
• Device Catalogue Number: 482400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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