MAUDE Adverse Event Report: LEVENTON DOSI-FUSER; 100 ML 48 HOUR ELASTOMERIC PUMP

Model Number L25915-100D2-USA

Device Problems Bent (1059); Failure to Infuse (2340); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/18/2017

Event Type  malfunction  

Event Description

Patient presented to clinic because her pump was no longer infusing medication.Label indicating volume and infusion rate provided by the manufacturer inside the pump capsule was bent and was impeding the level indicator.Contacted the mfr and they indicated that the pumps were recently upgraded putting so that the labels were now inside rather than outside the pump.Pump had to be disconnected and medication had to be put in a 24 hour pump.

• Brand Name: DOSI-FUSER
• Type of Device: 100 ML 48 HOUR ELASTOMERIC PUMP
• Manufacturer (Section D): LEVENTON; sesrovires, barcelona, es 08635
• MDR Report Key: 6731288
• MDR Text Key: 80778873
• Report Number: MW5071118
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: L25915-100D2-USA
• Device Lot Number: 170092L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 60 YR
• Patient Weight: 56