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

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dehydration (1807); Nausea (1970); Loss of consciousness (2418)

Event Date 01/02/2021

Event Type  malfunction  

Manufacturer Narrative

Infutronix is waiting for the device to be returned for evaluation.

Event Description

On 01/05/2021, a distributor of infutronix reported an issue on behalf of an end user: "white powder at the connection site of the pump to picc line and also on his arm.Daughter called to say that her father fainted yesterday and was taken to the ed by squad.Patient received iv fluids due to dehydration and that medical personnel mentioned he may be having reaction to chemotherapy.Patient is now home.Taking po fluids but feels like he is going to vomit.Advised to call oncologists and talk to physician on call.Daughter asked about giving ondansetron again - ordered every 8 hours.Advised to take ondansetron as prescribed.Reviewed how to call physician on call.Advised to tell physician on call what she has shared.If the physician wanted to nimbus pump to be turned off, to call back and i will assist in turning off pump." on 01/06/2021, the distributor of infutronix reported additional infomation on behalf of an end user: "patient reported when he got up this morning there was white powder at the connection site of the pump to picc line and also on his arm, medication infused was 5fu." device operator was a patient.A patient was involved but not harmed.The contract manufacturer of the device is (b)(4).

Event Description

This is a follow-up for the initially filed mdr 3011581906-2021-00001.

Manufacturer Narrative

On 02/23/2021, the distributor confirmed that the affected device was never returned for evaluation and therefore no root cause could be established.The complaint couldn't be confirmed.

• 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: 11225905
• MDR Text Key: 229361306
• Report Number: 3011581906-2021-00001
• Device Sequence Number: 1
• Product Code: FPA
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5FU CHEMO TREATMENT WAS BEING USED
• Patient Outcome(s): Other
• Patient Age: 78 YR