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

Model Number	HS-001
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Infutronix is waiting for the device to be returned for evaluation.
Event or Problem Description
On (b)(6) 2021, a distributor of infutronix reported an issue on behalf of an end user: "the tubing was separated.In the photo, it was clear that the tubing was somehow cut and the patient also made a comment that her cat might have bit it off." device operator was a patient.Medication infused was unknown.A patient was involved but not harmed.The contract manufacturer of the affected device is (b)(6) medical co.Ltd.
Additional Manufacturer Narrative
On 07/02/2021, infutronix confirmed with the service provider that the affected device was never returned 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 3011581906-2021-00045.

• 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
• MDR Report Key: 12097456
• Report Number: 3011581906-2021-00045
• Device Sequence Number: 19788260
• 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: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1