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

Model Number	HS-003
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 8800413
• Report Number: 3011581906-2019-00031
• Device Sequence Number: 19542744
• Product Code: FPA
• UDI-Device Identifier: 00817170020024
• UDI-Public: 00817170020024
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2019
• Initial 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
• Patient Age: 53 YR
• Patient Weight: 91