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	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Infutronix is waiting for the device to be returned for evaluation.
Event or Problem Description
On 06/26/2019, a distributor of infutronix reported a leaking issue.The distributor received the following information from the user facility: "we rounded on a patient and they stated their pump was leaking.The patient and nurse stated the fluid was coming from the actual pump (so likely the tubing clamped in the pump).The catheter site was completely dry." 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.The distributor has not provided the information for the infusion pump used at the time of the event.The contract manufacturer of the affected device is (b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr (3011581906-2019-00029).
Additional Manufacturer Narrative
The reported tubing leakage issue was confirmed.The administration set was tested on (b)(6)2019 and it was found that the administration set tubing connector was snapped off at the cassette proximal end, which was the leaking site.The way with which the connector piece broke in half indicated the pump was engaged to the cassette when force was applied at an angle to the side of the pump causing the connector to break.The affected set was scrapped after testing.

• 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: 8755321
• Report Number: 3011581906-2019-00029
• Device Sequence Number: 16566543
• Product Code: FPA
• UDI-Device Identifier: 00817170020017
• UDI-Public: 00817170020017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: Health Professional
• 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: 06/26/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1