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

Model Number HS-004

Device Problems Loss of or Failure to Bond (1068); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

The affected device is pending for the evaluation by service provider.

Event Description

On 06/25/2019, a distributor of infutronix reported a tubing bonding issue.The distributor received the following information from the user facility on 06/25/2019 that over the night the patient "got up in the middle of the night, dropped the pump and the tubing on the outflow side of the pump came out of the pump.He called customer service after reinserting the tubing and was told to turn off the pump, clamp the tubing and come in to see us first thing this morning.Other than losing 5 hours of infusion time, there was minimal leakage and no other problems.We replaced the tubing this morning and sent him home with the infusion resumed." the distributor reported that no patient was harmed and the medication infused was 5fu.The user facility representative reported that the lot number of the affected device was probably 1901003.The contract manufacturer of the affected device is (b)(4).

Manufacturer Narrative

The reported tubing detachment issue was confirmed.Visual inspection showed 5fu residue on the outside of the administration set and that the tubing was detached from the distal side of the cassette.A ring-shaped mark from the bonding was visible on the end of the detached tubing.See the attachment of this mdr for the picture of the affected device.- attachment: [evaluation photo.Jpg].

Event Description

This is a follow-up for the initially filed mdr (3011581906-2019-00028).

• 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
• MDR Report Key: 8747941
• MDR Text Key: 214104602
• Report Number: 3011581906-2019-00028
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00817170020031
• UDI-Public: 00817170020031
• Combination Product (y/n): N
• PMA/PMN Number: K153193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: HS-004
• Device Catalogue Number: HS-004
• Device Lot Number: 1901003
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 118