MAUDE Adverse Event Report: NULL; INFUSION PUMP

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

One level 1 hotline low flow system was returned for the evaluation of the reported issue.The device was received with a cracked and taped tank cover, broken pole clamp, and outdated pcb and power switch.A manufacturing dhr review, device history review, was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.The investigation started with a visual inspection then the tank was filled with water, temp check attached, line cord plugged in, and the power switch turned on.The cause of the issue was found to be that the device was out of calibration.No action was taken due to the age and condition of the device.It was deemed beyond economical repair and will be scrapped.

Event Description

Information was received regarding a level 1 hotline low flow system.It was reported that the device would not reach temperature.It is unknown if there was a patient involved.

• Type of Device: INFUSION PUMP
• Manufacturer (Section G): NULL
• MDR Report Key: 11743265
• MDR Text Key: 250324432
• Report Number: 3012307300-2021-03570
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1