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	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported tubing detachment issue was not confirmed.No root cause analysis could be performed, as the affected device was disposed at the user facility.No set was returned from the user facility for investigation.
Event or Problem Description
On (b)(6) 2019, a distributor of infutronix reported a tubing detachment issue: "pump was with patient in bed.Rn checked the shift total for charting information (pump was not removed from bag).Rn noticed the bag was wet and then unzipped it to find the iv set tubing completely disconnected from the distal end of the cassette connector." no patient information was reported to infutronix.No information on the medication used at the time of the event was available.No patient injury or harm was reported for this event.On (b)(6) 2019, the distributor reported that the affected device was discarded at the user facility.No information on the expiration date or manufacturing date of the affected device was available.The contract manufacturer of the affected device is (b)(4).

• 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: 8701067
• Report Number: 3011581906-2019-00022
• Device Sequence Number: 19318223
• 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): 06/07/2019

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: 06/11/2019
• 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