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

Model Number HS-003

Device Problem Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

The reported cassette backwards issue was confirmed.The picture provided by the service provider showed an administration set with backwards cassette.The tubing appeared to be installed backwards into the cassette, as if rotated 180 degrees from where it should be.The evaluation was completed on 07/05/2019.

Event Description

On 07/05/2019, a distributor of infutronix reported a cassette backwards issue.The distributor received an administration set with a note and a printed email from the user facility.The email stated the set was from lot # 1712004.The note stated "manufacturer defect.Green clamp on wrong end of the cassette." insuline and normal saline were the medications being infused.No patient injury or harm was reported for this event.The contract manufacturer of the affected device is (b)(4).

• Brand Name: ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): INFUTRONIX LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5083158201
• MDR Report Key: 8800413
• MDR Text Key: 200419201
• Report Number: 3011581906-2019-00031
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00817170020024
• UDI-Public: 00817170020024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: HS-003
• Device Catalogue Number: HS-003
• Device Lot Number: 1712004
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 91