MAUDE Adverse Event Report: I-FLOW/HALYORD HEALTH HOMEPUMP C-SERIES ELASTOMERIC PUMP

Model Number C270050

Device Problems Improper Flow or Infusion (2954); Noise, Audible (3273)

Patient Problem Underdose (2542)

Event Date 12/29/2016

Event Type  malfunction  

Event Description

Device connected (b)(6) 2016 at 2pm to be infused at home for 46 hours.At 4am on (b)(6) 2016 the patient heard a sucking sound and reached over to feel dosifuser which felt empty.Pt came into infusion room on (b)(6) 2016 to be disconnected from dosifuser which was empty in am.Dose or amount: 270ml volume.Frequency: over 46 h.Route: mediport.Diagnosis or reason for use: colon cancer.Is the product compounded: yes.Is the product over-the-counter: no.

• Brand Name: HOMEPUMP C-SERIES ELASTOMERIC PUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW/HALYORD HEALTH; roswell GA
• MDR Report Key: 6282846
• MDR Text Key: 66079408
• Report Number: MW5067514
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/05/2017

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: 08/30/2018
• Device Model Number: C270050
• Device Catalogue Number: C270050
• Device Lot Number: 0202319200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 61