MAUDE Adverse Event Report: HALYARD HEALTH HOMEPUMP C-SERIES ELASTOMERIC PUMP, 5ML/HR ML; PUMP, INFUSION, ELASTOMERIC

Lot Number 0203104459

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2019

Event Type  Injury  

Event Description

The 5fu bulb was still full when pt came in for disconnect.Tubing was unclamped and port flushed with good blood return noted.Bulb appeared to be defective.

• Brand Name: HOMEPUMP C-SERIES ELASTOMERIC PUMP, 5ML/HR ML
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH; alpharetta GA 30004
• MDR Report Key: 8479683
• MDR Text Key: 140942577
• Report Number: MW5085552
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2021
• Device Lot Number: 0203104459
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 98