MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP CURLIN 6000 CMS IV INFUSION PUMP

Model Number 360-1400P

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

The initial reporter stated that they could not calibrate the pump volume.When the pump was returned to mmdg, the pump under infused.At the time of the complaint the initial reporter advised that no patient had been involved and that the complaint had occurred during testing.The volumetric failure was discovered at moog.(b)(4).

Manufacturer Narrative

The device was returned to mmdg for investigation.A dhr review was conducted and no non-conformances were found.When the device was returned to mmdg for investigation, it was found that the pump was out of calibration, which caused the volumetric failure.The pump was serviced to correct this issue.

• Brand Name: CURLIN 6000 CMS IV INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 18759921
• MDR Text Key: 336855199
• Report Number: 1722139-2024-00121
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 360-1400P
• Device Catalogue Number: 360-1400P
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1