MAUDE Adverse Event Report: HALYARD ECLIPSE HOMEPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number E251750

Device Problem Burst Container or Vessel (1074)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2018

Event Type  malfunction  

Event Description

Two eclipse homepumps (model # e251750, lot # 0202862396) containing vancomycin 1.75 grams in 0.9 percent sodium chloride 250 ml exploded while in shipping (2 balls were empty and fluid in all bags).

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD; alpharetta GA 30004
• MDR Report Key: 7295826
• MDR Text Key: 101061302
• Report Number: MW5075493
• Device Sequence Number: 2
• 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: 02/21/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E251750
• Device Lot Number: 0202862396
• 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: 02/23/2018
• 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