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

Model Number	383400
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Feeding Problem (1850)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the device overfed during testing by 18%.
Additional Manufacturer Narrative
H3 evaluation summary: the service history record was reviewed showing no previous issues.The unit was evaluated, and the reported condition could not be confirmed.The unit was functioning as expected during evaluation.Preventative maintenance was performed on the unit.A corrective and preventative action (capa) is not applicable since the reported event could not be confirmed though the evaluation of the returned device.This complaint will be used for tracking and trending purposes.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12374573
• Report Number: 1282497-2021-10574
• Device Sequence Number: 3901516
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1