MAUDE Adverse Event Report: COVIDIEN COVIDIEN KANGAROO PUMP

Model Number IPX1

Device Problem Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2017

Event Type  malfunction  

Event Description

Kangaroo pump runs on its own and not on accurate time pump is set for.

• Brand Name: COVIDIEN KANGAROO PUMP
• Type of Device: COVIDIEN KANGAROO PUMP
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 6493015
• MDR Text Key: 72921094
• Report Number: MW5069083
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2017
• Device Model Number: IPX1
• Device Lot Number: EIN 960923
• Other Device ID Number: EIN 960923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR