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	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor of infutronix received a complaint from a pharmacist, reportedly the patient went to the hospital for a scheduled blood transfusion and passed away "shortly after arriving to the hospital"."the hospital put everything in a bag along with the drug/fluid bag." the "tubing was not clamped when it was disconnected and the medication, blincyto, leaked out".The bag and tubing were retained for a short time after the product was received from the hospital.During that time, the reporter indicated they "did hook it up to another pump and did test it with a nursing supervisor." during the testing they "could not find any leaks in the tubing or the bag.It was very hard to replicate the occlusion error the way a picc line would." the testers "clamped it off, tried to slightly occlude it but it would never leak anywhere." the reporter later clarified: "the picc line discussion occurred with an employee at zyno solutions.Picc lines can sometimes cause occlusions.It is a side note that the patient had a picc line since we did not have all the information on where and how the pump was damaged.Upon finding more information out the picc line pressure did not cause the leak." medication being infused was blincyto.Operator of the device was a patient.Patient was under treatment for acute lymphoblastic leukemia (all) at the time of death.Per the reporter: "the medical product was not result of the patient passing away, the patient had a cancer diagnosis, and was not doing well." "i do not believe that the cause of death has anything to do with the pump." the event of death is therefore not considered device related.The contract manufacturer of the affected device is podo xingda (tianjin) medical co.Ltd.
Additional Manufacturer Narrative
Return of the device was requested, but the reporter confirmed that the device has been discarded.

• 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: 16400601
• Report Number: 3011581906-2023-00010
• Device Sequence Number: 12160690
• Product Code: FPA
• UDI-Device Identifier: 00817170020031
• UDI-Public: 00817170020031
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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: 06/14/2025
• Device Model Number: HS-004
• Device Catalogue Number: HS-004
• Device Lot Number: 2206013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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: 77 YR
• Patient Sex: Female