MAUDE Adverse Event Report: HALYARD/AVANOS MEDICAL, INC HOMEPUMP C SERIES; PUMP, INFUSION, ELASTOMERIC

Model Number K-CC300060

Device Problem Failure to Deliver (2338)

Patient Problem Missed Dose (2561)

Event Date 02/08/2019

Event Type  malfunction  

Event Description

Patient was fitted with bsa based calculated dose of fluorouracil placed in home pump c series (model# k-cc300060.Nominal fill volume 300ml.Rate 6ml/hr) as part of folfox6 regimen to be infused over 48hrs.Upon return, it was discovered by the nursing staff that ¾ of the content of the medication was still in the device.All clams were noted as open.Patient was deemed as having missed the intended dose.

• Brand Name: HOMEPUMP C SERIES
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD/AVANOS MEDICAL, INC; east orange NJ 07018
• MDR Report Key: 8343210
• MDR Text Key: 137122824
• Report Number: MW5084082
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• 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: 02/13/2019

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 Model Number: K-CC300060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 61