MAUDE Adverse Event Report: HALYARD HEALTH INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) HALYARD HUMP PUMP SERIES C ELASTOMERIC PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number C270020

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Nausea (1970); Ulcer (2274)

Event Date 01/21/2021

Event Type  malfunction  

Event Description

Pt received halyard homepump c-series elastomeric pump model# c270020 270 ml 2 ml/hr to infuse fluorouracil over 96 hours.Pump attached (b)(6) 2021 at 1228.Clinic contacted (b)(6) 2021 1131 that pt was concerned that the pump was empty and that she noticed it empty last night.When pt arrived at clinic, rn confirmed the correct pump was dispensed and calculations were correct.No obvious leaks or defects with pump per pt.Pt experienced nausea and mouth sores from shorter than expected duration of infusion.Fda safety report id# (b)(4).

• Brand Name: HALYARD HUMP PUMP SERIES C ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 11272301
• MDR Text Key: 230327720
• Report Number: MW5099150
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C270020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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): Other
• Patient Age: 66 YR
• Patient Weight: 67