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

Model Number D-1233-01-S

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2014

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that before the patient underwent a paroxysmal atrial fibrillation (afib) procedure with a coolflow tubing set, a foreign material was found in the tubing set.Before the procedure and when the sterile package was opened, a black foreign material about 2mm was found inside the tube.The issue was resolved by changing the tubing set.The procedure was completed without patient's consequence.Upon receipt, the tubing was visually inspected and foreign material was found inside the tube, approximately 7 inches from the 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 pvc.This is related with the tubing manufacturing and an internal corrective action has been opened to investigate this issue.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.

Event Description

It was reported that before the patient underwent a paroxysmal atrial fibrillation (afib) procedure with a coolflow tubing set, a foreign material was found in the tubing set.Before the procedure and when the sterile package was opened, a black foreign material about 2mm was found inside the tube.The issue was resolved by changing the tubing set.The procedure was completed without patient's consequence.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

• 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: 4073957
• MDR Text Key: 12803099
• Report Number: 2028523-2014-00001
• 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: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2014
• 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