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	Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has not yet been returned to the distributor.
Event or Problem Description
On 06/10/2019, a distributor of infutronix reported a tubing detachment issue: "iv set tubing detached from distal end of cassette connector site".No information on the medication used at the time of the event was available.No patient information or injury was reported to infutronix.No information on the expiration date or manufacturing date of the affected device was available.The contract manufacturer of the affected device is podo xingda ((b)(4)) medical co.Ltd.
Additional Manufacturer Narrative
The reported tubing detachment issue was confirmed.The administration set tubing was completely detached from the cassette on the distal end.No signs of physical damage were present.The administration set had a bonding issue at the cassette connector site (distal end).The affected administration set has been scrapped after testing.
Event or Problem Description
This is a follow-up for the initially filed mdr (3011581906-2019-00021).

• 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: 8701071
• Report Number: 3011581906-2019-00021
• Device Sequence Number: 2256547
• Product Code: FPA
• UDI-Device Identifier: 00817170020017
• UDI-Public: 00817170020017
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: Other
• Device Model Number: HS-001
• Device Catalogue Number: HS-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1