MAUDE Adverse Event Report: LEVENTON S.A.U. DOSI-FUSER ELASTOMETRIC PUMP

Model Number L25915-250D2-USA

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911); Incorrect Device Or Component Shipped (2962)

Patient Problem No Code Available (3191)

Event Date 01/23/2015

Event Type  Injury  

Event Description

Piloting new elastometric pump dosi-fuser mfg by leventon distributed by (b)(4).Received incorrect product from (b)(4) distribution due the all labeled packaging/pump for 2 day pump are color labeled orange.Ordered 150 ml 2.8 ml/hr pump; however, (b)(4) distribution ctr sent 250 ml 4.7 ml/hr pump.Received two boxes for the 250 ml size.Pilot and ctr caught the error brought to (b)(4) rep's awareness and (b)(4) distribution ctr sent correct product orange labeled 150 ml 2.8 ml/hr pump.Error occured three days later (during pilot phase) when tech grabbed 250 ml 4.7 ml/hr pump instead of 150 ml 2.8 ml/hr pump and filled with chemotherapy fluorouracil and pharmacist checked product.Staff was not aware that pilot site had two sizes in stock as (b)(4) did not want med ctr site to return 250 ml size pump.Due to pump looking exactly the same with orange labeling and staff not aware that two sizes were in stock, pt received incorrect product which lead to pump infusion in 29 hours instead of 46 hours.

• Brand Name: DOSI-FUSER ELASTOMETRIC PUMP
• Type of Device: PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; barcelona ; SP
• MDR Report Key: 4707014
• MDR Text Key: 5652464
• Report Number: MW5042131
• Device Sequence Number: 1
• 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: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: L25915-250D2-USA
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 141727L
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 80