MAUDE Adverse Event Report: CLEARFLOW INC PLEURAFLOW SYSTEM; POWERED SUCTION PUMP, OTK, GBX

Model Number PF-32

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: physical inspection was conducted on (b)(6) 2015.The clearance wire assembly of the device showed significant deformation inconsistent with normal use.External forces, the nature of which is unknown at this time, may have caused the damage.Additional analysis is pending.

Event Description

The clearance loop portion of the pleuraflow system separated from the clearance wire and remained inside the guide tube portion of the device.The guide tube is external to the patient and connects the chest tube to the drainage canister.The guide tube was removed and the chest tube remained and continued draining.

• Brand Name: PLEURAFLOW SYSTEM
• Type of Device: POWERED SUCTION PUMP, OTK, GBX
• Manufacturer (Section D): CLEARFLOW INC; 1630 s sunkist st ste e; anaheim CA 92806 0000
• Manufacturer (Section G): XERIDIEM; 4700 south overland dr.; tucson AZ 85714
• Manufacturer Contact: 1630 s sunkist st. ; ste e; anaheim, CA 92806 ; 7149165014
• MDR Report Key: 5070191
• MDR Text Key: 25697383
• Report Number: 3008782989-2015-00002
• Device Sequence Number: 1
• Product Code: OTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: PF-32
• Device Lot Number: 8962-04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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
• Patient Age: 72 YR
• Patient Weight: 92