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

Lot Number C103-KIT

Device Problems Break (1069); Leak/Splash (1354); Positioning Problem (3009)

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

Event Date 04/10/2014

Event Type  malfunction  

Event Description

Customer reported a blood leak into the centrifuge chamber because the centrifuge bowl moved out from the base at 140 ml of whole blood processed.The centrifuge leak detect strip is now broken.The nurse does not remember if an alarm occurred.Treatment was aborted and no blood was returned to the patient.Customer stated that the patient condition was stable.Service order# (b)(4) will be dispatched to inspect/repair the instrument as needed.No product will be returned by the customer for investigation.

Manufacturer Narrative

A review of c103 was performed.There were no nonconformances associated with this lot this lot met release requirements.(b)(4) service order feedback: field engineer replaced the centrifuge leak strip and completed full check out procedure and calibrates pumps.Emailed check out reports to customer.Service complete.Trends have been reviewed on a lot by lot basis for this complaint category and no trend has been detected for this specific lot.However, capa (b)(4) is currently ongoing to investigate cellex bowl breaks/leaks.The assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation.Therefore, it is not possible to determine if this specific product met specifications.Complaints of this nature are monitored through tracking and trending.Should a trend arise further action will be taken as deemed appropriate.(b)(4).

• Brand Name: THERAKOS CELLEX PHOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east suite 140; bridgewater, NJ 08807
• MDR Report Key: 3948675
• MDR Text Key: 4536911
• Report Number: 2523595-2014-00137
• 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: 04/10/2014

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: 01/01/2016
• Device Lot Number: C103-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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