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	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported "infusion leaking at the filter".Reportedly the patient stated they "had a paper towel around it when they went to bed last night and woke up at 2am with a few spots on the paper towel.Patient put a new paper towel around it and covered with saran wrap and came to the clinic first thing this morning".The tubing was not broken, separated, cracked, or detached.There was no visible harm to the filter."patient came back to the clinic to have the tubing changed, when they returned on friday patient stated there was air in the tubing until it reached the filter then would be just medication past the filter.Patient stated they had to open up the fanny pack the bag was in and sit it next to them to not have it alarm." medication being infused was epoch - doxorubicin, etoposide, vincristine in a 1000ml bag to infuse over 48 hours.No patient injury reported.
Additional Manufacturer Narrative
Return of the device has been requested.As of the date of this report, device has not been returned.

• 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: lorraine hanley ; 177 pine street; natick, MA 01760 ; 5083158230
• MDR Report Key: 17004225
• Report Number: 3011581906-2023-00087
• Device Sequence Number: 15026701
• Product Code: FPA
• UDI-Device Identifier: 00817170020031
• UDI-Public: 00817170020031
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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: 06/18/2021
• 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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male