FDA Adverse Event Malfunction Summary report: N

CURLIN INFUSION IV PUMP

MDR report key: 3810367 · Received April 11, 2014

Report

Report Number
1722139-2014-00094
Event Type
Malfunction
Date Received
April 11, 2014
Date of Event
March 13, 2014
Report Date
March 13, 2014
Manufacturer
MOOG MEDICAL DEVICES GROUP
Product Code
FRN
PMA / PMN Number
K981816
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

PUMP'S PLATEN DOOR WAS REPLACED TO RESOLVE THE ISSUE.

Description of Event or Problem · 1

INVESTIGATION FOUND THAT PUMP'S PLATEN DOOR WAS NOT WORKING CAUSING PUMP FAILED THE FREE FLOW TEST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
221610 CURLIN INFUSION IV PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 4000 CMS

Patients

Seq Age Sex Outcome Treatment
1