MAUDE Adverse Event Report: IFLOW HOMEPUMP ECLIPSE

Lot Number 0202219871

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problems Fatigue (1849); Pain (1994); Underdose (2542)

Event Date 12/23/2015

Event Type  Injury  

Event Description

I receive enzyme replacement therapy (an orphan drug) for a super rare disorder called gaucher disease.I get home infusions and use the iflow 400ml/100ml per hour pump (lot #0202219871).I receive ert every two weeks.My past infusion on (b)(6) 2015 the iflow malfunctioned.The pump stopped flowing leaving about 75% of my drug in it.Not having my full dose of drug has negative effects on my symptoms including bone pain and chronic debilitating fatigue.

• Brand Name: HOMEPUMP ECLIPSE
• Type of Device: HOMEPUMP ECLIPSE
• Manufacturer (Section D): IFLOW
• MDR Report Key: 5340872
• MDR Text Key: 35007876
• Report Number: MW5058815
• Device Sequence Number: 1
• Product Code: MEB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2015

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: No Information
• Device Lot Number: 0202219871
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability