MAUDE Adverse Event Report: ARMM, INC. COOLFLOW® TUBING SET; CATHETER, ELECTRODE RECORDING

Model Number D-1233-01-S

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

It was reported that a foreign material was found in a coolflow tubing set when priming was started after the tubing set was taken out from the package.The issue was resolved by changing the tubing set.The procedure was completed without patient consequence.

Manufacturer Narrative

When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

Evaluation summary: (b)(64.It was reported that a foreign material was found in a coolflow tubing set when priming was started after the tubing set was taken out from the package.The issue was resolved by changing the tubing set.The procedure was completed without patient consequence.Upon receipt, the tubing was visually inspected and foreign material was found in the valve (stopcock) of the tubing.In addition, the coolflow tubing was cut 8 inches from drip chamber.A ft-ir test was performed to in order to identify the type of foreign material.The results demonstrated that the particle was primarily composed of silicon.An internal corrective action was opened to investigate this issue.For the drip chamber condition, it remains unknown how it was cut.Further information was requested to the affiliate but it was not possible to get any additional information.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.However the root cause remains unknown.An internal corrective action has been opened to investigate this issue.

• Brand Name: COOLFLOW® TUBING SET
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARMM, INC.; 17744 sampson ln; huntington beach CA 92647
• Manufacturer (Section G): ARMM, INC.; 17744 sampson ln; huntington beach CA 92647
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4087942
• MDR Text Key: 4744524
• Report Number: 2028523-2014-00004
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990071/S5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1233-01-S
• Device Catalogue Number: CFT001
• Device Lot Number: OEM_D-1233-01-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1