MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW

Model Number 382400

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/03/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an epump.The customer states bad circulation and not pulling off.Upon triage a tech found a leaking gearbox, making this reportable.

Manufacturer Narrative

This complaint was filed in error.This is not a reportable event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: EPUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6218035
• MDR Text Key: 63875225
• Report Number: 3006451981-2017-00006
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Device Lot Number: C1154232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1