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

Model Number	HS-001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor of infutronix received a complaint from a healthcare professional (hcp) reporting "the admin set tubing fell apart".Tubing disconnected from the cassette at the proximal end, and leaked.Patient returned to the facility to get further attention and to return the defective tubing.Device operator was the patient.Medication being infused was unknown.No patient injury reported.The contract manufacturer of the affected device is podo xingda (tianjin) medical co.Ltd.
Additional Manufacturer Narrative
Infutronix is waiting for the affected device to be returned.Further information from the reporter regarding event, product, and patient details has been requested.No additional information is available at this time.
Additional Manufacturer Narrative
Device evaluation: a visual inspection was performed on the hs-001 (lot unknown) administration set, and it was observed that the tubing was separated from the proximal end of the cassette.The report complaint of "admin set tubing fell apart" has been confirmed.The possible cause of the leaking may be a bonding issue on the proximal end of the cassette.Capa initiated: it2021-17.

• 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: 15574433
• Report Number: 3011581906-2022-00193
• Device Sequence Number: 6077331
• Product Code: FPA
• UDI-Device Identifier: 00817170020017
• UDI-Public: 00817170020017
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Model Number: HS-001
• Device Catalogue Number: HS-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown