MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

Model Number	383400
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Codes	Full thickness (Third Degree) Burn (2696); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the device has not been received for evaluation.If the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The initial reporter stated that there was a house fire which caused substantial damages.There were two medical devices within the area of origin of this fire; a kangaroo joey enteral feed and flush pump, manufactured by cardinal health and supplied by (b)(4) and a su 100 dc portable suction machine, manufactured by sunset healthcare solutions, inc and supplied by other companies.There has been no determination that the kangaroo joey enteral feed and flush pump was involved in the fire.The investigation into the cause of the fire is ongoing.
Additional Manufacturer Narrative
Additional information was received on 02aug2023 resulting in the following sections being updated: a3 added the patient's gender; b1 selected adverse event; b2 selected disability or permanent damage; b5 added additional verbiage to the event description; d4 added the device's serial number; h1 updated to serious injury; h2 selected additional information; h6 added codes to health effect ¿ clinical code and health effect ¿ impact code.
Event or Problem Description
The initial reporter stated that there was a house fire which caused substantial damages.There were two medical devices within the area of origin of this fire; a kangaroo joey enteral feed and flush pump, manufactured by cardinal health and supplied by option care health, inc.; and a su 100 dc portable suction machine, manufactured by sunset healthcare solutions, inc and supplied by other companies.There has been no determination that the kangaroo joey enteral feed and flush pump was involved in the fire.The investigation into the cause of the fire is ongoing.Additional information received 02aug2023 via the cardinal health litigation team: the customer's son was lying on a bed of blankets and pillows with the feeding pump and a portable suction machine nearby (suction machine is a not a cardinal health device).The customer alleges either the feeding pump or the portable suction machine malfunctioned and started a fire.The customer stated that their son, a quadriplegic minor, suffered permanent and substantial personal injuries including third-degree burns which required extensive medical treatment and care.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12293749
• Report Number: 1282497-2021-10537
• Device Sequence Number: 14550944
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Male