MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - RFB; PUMP, INFUSION, ENTERAL

Model Number	382401
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The pump, s/n:c1001991, was received.The pump could not be tested as it was received in a damaged condition and the front case was cracked.However there was damage to the pcba observed.The reported issue was confirmed.The device was manufactured in (b)(6)and this the first time this serial number was returned for service.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.
Event or Problem Description
The customer reported that the device has burnt case.

• Brand Name: KANGAROO EPUMP - RFB
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12072746
• Report Number: 1282497-2021-10343
• Device Sequence Number: 4827351
• Product Code: LZH
• UDI-Device Identifier: 10884521006621
• UDI-Public: 10884521006621
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2021

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: No Information
• Device Model Number: 382401
• Device Catalogue Number: 382401
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 06/26/2021
• Patient Sequence Number: 1