MAUDE Adverse Event Report: HALYARD-AVANOS MEDICAL, INC. ECLIPSE HOMEPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number E251750

Device Problem Failure to Infuse (2340)

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

Event Date 08/04/2019

Event Type  malfunction  

Event Description

Eclipse homepump (model # e251750, lot # 0202946930) containing vancomycin 1500 mg in 0.9% sodium chloride 250 ml would not infuse after being connected for over an hour.Picc line flushes with no problem.Disconnected, no dripping with clamp open.Fda safety report id # (b)(4).

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD-AVANOS MEDICAL, INC. ; alpharetta GA 30004
• MDR Report Key: 8883479
• MDR Text Key: 154119727
• Report Number: MW5088942
• 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: 08/07/2019

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: Lay User/Patient
• Device Model Number: E251750
• Device Lot Number: 0202946930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1