MAUDE Adverse Event Report: HALYARD HEALTH ECLIPSE PUMP; ELASTOMERIC PUMP

Model Number E101000

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2016

Event Type  malfunction  

Event Description

Pt returned to us on elastomeric pump that began to leak as soon as the pump was activated.The pump tubing has an attached 0.22 mm bubble filter, the leak was at the filter.We have had many complaints from pts about pump tubing breaking off or leaks prior to use.Of these we have been able to recover, and return, five pumps.

• Brand Name: ECLIPSE PUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD HEALTH
• MDR Report Key: 5892899
• MDR Text Key: 52766990
• Report Number: MW5064202
• Device Sequence Number: 4
• 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: 08/04/2016
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E101000
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other