MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	BSPFF
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the pump was alarming and there were a lot of fine bubbles in the tubing between the feed spike and the pump.The pump alarmed immediately after being connected, saying there was a problem between the bag and the pump.They removed the set and got another set.
Additional Manufacturer Narrative
The device history record (dhr) review showed that manufacturing and inspection of the product was performed as per applicable procedures and validated processes.One sample was received for evaluation.A visual inspection was carried out confirming that the sample received is within the allowed range, based on the quality requirements.Functional tests were carried out and no anomaly was detected that is outside the quality standards.The reported condition is not confirmed.A possible root cause cannot be determined.No additional actions were required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20406614
• Report Number: 1423537-2024-00206
• Device Sequence Number: 12327711
• Product Code: LZH
• UDI-Device Identifier: 10885380177156
• UDI-Public: (01)10885380177156(17)260228(10)2308019164
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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
• Device Expiration Date: 02/28/2026
• Device Model Number: BSPFF
• Device Catalogue Number: BSPFF
• Device Lot Number: 2308019164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown