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

Model Number	HS-001
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: "i returned your machine with remaining medication.You need to understand that your device has significant flaws.Doctors and nurses said there have been many times where the cord separates.They even tried to tape it to protect it." end user was notified when receiving the note and the end user was able to clarify where there was a separation: the tubing itself became separated, disconnected from the catheter connector and was not able to be reconnected to the catheter even with clinical instructions.Device operator was a patient.Medication infused was unknown.A patient was involved but not harmed.The contract manufacturer of the affected device is podo xingda (tianjin) medical co.Ltd.
Event or Problem Description
This is a follow-up for the initially filed mdr 3011581906-2021-00024.
Additional Manufacturer Narrative
On 08/25/2021, infutronix confirmed with the service provider that the affected device was lost in transit and therefore no root cause could be established.The reported issue was not confirmed.

• Brand Name: ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• MDR Report Key: 11828472
• Report Number: 3011581906-2021-00024
• Device Sequence Number: 1085509
• 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): 08/26/2021

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: 04/22/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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