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 Consequences Or Impact To Patient (2199)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported tubing detachment issue was confirmed.The picture provided by the end user showed an administration set with detached tubing.No root cause analysis could be performed, as the affected device was disposed at the user facility.
Event or Problem Description
On 06/06/2019, a distributor of infutronix reported a tubing detachment issue: "iv set lot# is unknown and the set will be returned for evaluation.There was patient involvement, but there was no patient injury.Tubing did not leak.The tubing became entirely detached from cassette connector site.I have attached photos." no patient information was reported to infutronix.No information on the medication used at the time of the event was available.On 06/13/2019, the distributor reported that the user facility had disposed the affected device.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 (tianjin) medical co.Ltd.

• 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: 8701072
• Report Number: 3011581906-2019-00020
• Device Sequence Number: 2473017
• 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
• Report Date (Section B): 06/06/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1