MAUDE Adverse Event Report: HAYLARD/AVANOS MEDICAL (LAB) - IRVINE ELASTOMERIC HOME C SERIES PUMP 1 CYCLE 2-DAY; PUMP, INFUSION, ELASTOMERIC

Device Problems Failure to Pump (1502); Component Missing (2306); Gas/Air Leak (2946)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 03/13/2019

Event Type  Injury  

Event Description

In 17-hours after halyard home pump c series elastomeric pump 2-day 5fu (3,800 mg, 25% dose reduction) patient arrived to cancer center the next day, wednesday 8:40 am stating the pump was not infusing.Upon examination, i noticed a small bubble in the sensor.I was able to remove the bubble.We use equashield cstd these pieces were replaced and function tested.Patient is cycle 12 (cycles 1-9 dossifuser system; cycles 10-12 haylard pump device).Dose reduction 25% began with cycle 5 secondary to neutropenia, anc 4000.Cycle 2-4 is dose reduced 10% for anc 1000-1800.He received neulasta at pump disconnect with cycle 12 as he has with his pump cycles.7hrs later the same day, the patient arrived not sure if the pump was infusing.Twenty-five minutes later, a new pump was connected.Old pump #1 and equashield cstd #2 were sent to pharmacy to report out to the manufacturer.I inspected the ball inside the pump.It slightly less full.The time infused perhaps.Thursday 8 am patient (16 hrs after pump #2 connected) returned stating "pump too full for timeline".Nurse assessed port and flushed.Friday 1:15 pm "5fu pump disconnected" per nursing completely empty.Patient stated he was having difficulty swallowing this morning.But better now.Advised to call if symptom returned.Pump disposed not kept.Monday morning patient calls to report difficulty swallowing returned saturday.Early onset gastrointestinal symptom within 96 hours so vistogard was ordered and administered.Mostly likely first pump delivered approx.10ml (500 mg, 25% dose) + pump #2 over 16-24 hours or simply both pumps malfunctioned.We do not have the second pump to return to halyard to investigate.The patient has been on a different elastomeric pump device with no problems, dossifuser.However, this pump device does not have a hard plastic shell as dossifuser.The patient states he did nothing different.

• Brand Name: ELASTOMERIC HOME C SERIES PUMP 1 CYCLE 2-DAY
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HAYLARD/AVANOS MEDICAL (LAB) - IRVINE
• MDR Report Key: 8459783
• MDR Text Key: 140434132
• Report Number: MW5085264
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• 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: 03/25/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 93