• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EPIC PROGRESSIVE MEDICAL EZ PUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8499470
MDR Text Key141470616
Report Number8499470
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Number of Events Reported1
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
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 FDA02/28/2019
Event Location Other
Date Report to Manufacturer04/10/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-