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	02/07/2022
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 02/08/2022, infutronix received a complaint from an end user: "an administration set model hs-004, lot 2106005, set was leaking from the sides of the filter.The patient had noticed her shirt had gotten wet." 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
On 04/22/2022, infutronix confirmed with the service provider that the affected device was discarded by the end user and therefore no root cause could be established.The reported issue was not confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr 3011581906-2022-00018.

• 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: 13652109
• Report Number: 3011581906-2022-00018
• Device Sequence Number: 2519022
• Product Code: FPA
• UDI-Device Identifier: 00817170020031
• UDI-Public: 00817170020031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2021
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Female