MAUDE Adverse Event Report: EPIC PROGRESSIVE MEDICAL EZ PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problems Infusion or Flow Problem (2964); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/27/2019

Event Type  malfunction  

Event Description

Late (b)(6) 2019, patient was connected to an ez pump (epic progressive medical) with 5 fu on monday for 46 hrs infusion.Return today to be disconnected.Pump is approximately 2/3 to 3/4 infused but still small amount not infused completely.Checked all the connections and clamps are closed with the infusion lines running on the outside of the clamp.Late (b)(6) 2019, infusion pump didn't empty all the way.Mid (b)(6) 2019, infusion pump only half empty, supposed to be empty.Clamps in place correctly, good blood return when flushed.Mid-(b)(6) 2019, pt connected to home infusion ez pump, but two days later pump was not empty as scheduled.Pt instructed to stay connected to the pump for an additional 48 hours.Pt arrived to 7th floor for pump disconnect.Pump disconnected by rn.Ez pump was not empty.Early (b)(6) 2019, home infusion ez pump malfunctioned and did not complete transfusion.It was returned to oncology infusion center as requested for tracking.I was instructed to save all the malfunctioning ez pumps for the rep.The manufacturer was notified as well as the rep.An in-service was scheduled to rule out any operator errors and problem shoot product.We are currently monitoring the transfusion of the new ez pump bulbs.Nurse manager, physicians, director of pharmacy, lead pharmacist, ez pump reps and oncology infusion staff are all working together to determine the reason for error in transfusion to the patients using the new pumps.Manufacturer response for ez pump, ez pump (per site reporter).An in-service has been set up with pharmacy, field rep and nursing to review the malfunction and look at user operator vs.Pump malfunction.

• Brand Name: EZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC PROGRESSIVE MEDICAL; registrar corp; 144 research drive; hampton VA 23666
• MDR Report Key: 8499470
• MDR Text Key: 141470616
• Report Number: 8499470
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2019
• Event Location: Other
• Date Report to Manufacturer: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1