MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX PHOTOPHERIS SYSTEM

Lot Number C139 - KIT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

Customer reported drive tube break during buffy coat collection.The customer stated they aborted the procedure with no return of blood/products to the pt.There were no alarms prior to drive tube break and there were no alarms during prime.The customer stated no there was no clotting or occlusion noted in the kit.Pt is in stable condition.Photos were returned for eval.Service order (b)(4) was generated.

Manufacturer Narrative

A review of lot c139 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.Trends were reviewed for complaint category, drive tube leak/break.A downward trend was detected for drive tube leak/break.Drive tube breaks were investigated through capa (b)(4), which has been closed, and capa (b)(4).Service order, (b)(4), feedback: field engineer cleaned the instrument and carried out the checkout procedure.No further action required.The assessment is based on info available at the time of the investigation.Eval of the photographs is still in progress at the time of this report.A supplemental report will be filed when this analysis is complete.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4361494
• MDR Text Key: 5289892
• Report Number: 2523595-2014-00311
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Lot Number: C139 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 59 YR
• Patient Weight: 60