MAUDE Adverse Event Report: INFUTRONIX, LLC. ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP; IV ADMINISTRATION SET

Model Number	HS-004
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Infutronix is waiting for the affected device to be returned for evaluation.
Event or Problem Description
On (b)(6) 2022, infutronix received a complaint from an end user: "she went to change her blouse and noticed there was a wet spot.She said she took the medication out of the bag and noticed her dressing was wet." infutronix followed up with the user facility, the registered nurse (b)(6) from (b)(6) cancer specialist confirmed the tubing was leaking from the edge of the filter during the infusion.Device operator was a patient.Medication infused was 5fu.A patient was involved but not harmed.The contract manufacturer of the affected device is (b)(6) medical co.Ltd.
Additional Manufacturer Narrative
Infutronix is waiting for the affected device to be returned for evaluation.
Event or Problem Description
On (b)(6) 2022, infutronix received a complaint from an end user: "she went to change her blouse and noticed there was a wet spot.She said she took the medication out of the bag and noticed her dressing was wet." infutronix followed up with the user facility, the registered nurse (b)(6) from (b)(6) cancer specialist confirmed the tubing was leaking from the edge of the filter during the infusion.Device operator was a patient.Medication infused was 5fu.A patient was involved but not harmed.The contract manufacturer of the affected device is (b)(4) medical co.Ltd.
Additional Manufacturer Narrative
A service provider of infutronix provided the evaluation report for the affected administration set on (b)(6) 2022.Inspection confirmed that the leaking happened at the tubing connecting to the 1.2 micron air eliminating filter.The reported issue was confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr 3011581906-2022-00006.

• Brand Name: ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): INFUTRONIX, LLC.; 177 pine street; natick MA 01760
• Manufacturer (Section G): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 13497674
• Report Number: 3011581906-2022-00006
• Device Sequence Number: 17217356
• Product Code: FPA
• UDI-Device Identifier: 00817170020031
• UDI-Public: 00817170020031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: Lay User/Patient
• Device Expiration Date: 06/18/2024
• Device Model Number: HS-004
• Device Catalogue Number: HS-004
• Device Lot Number: 2106005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female