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

Lot Number C146-KIT

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems Complaint, Ill-Defined (2331); Blood Loss (2597)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

The customer reported a drive tube break during buffy coat collection.The treatment was aborted.The patient received an iv transfusion of crystalloid solution in order to compensate for the fluid loss.The patient was reported to be in stable condition.The customer stated in an update on (b)(6) 2015, that a blood leak alarm had occurred during the treatment and this was why the centrifuge stopped.The customer also stated that the patient had received an unplanned 500 ml blood transfusion after the next days treatment in order to raise his hematocrit.The customer did not have the patient's hematocrit values available.Service order, (b)(4), was generated.The kit was not returned for evaluation, however pictures were returned for investigation.

Manufacturer Narrative

A batch record review of lot c146 was conducted.There were no nonconformances related to the complaint.The lot met release requirements.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: (centrifuge chamber).No trend was detected for these complaint categories.Drive tube leak/break was investigated through capa (b)(4) and capa (b)(4).Capa (b)(4) was closed.No capa was initiated for complaint category, alarm #7: blood leak (centrifuge chamber).Service order, (b)(4), feedback: the service technician replaced the damaged leak detector strip, checked and tightened the drive tube retaining clips, cleaned the inside of the centrifuge chamber, and performed the system checkout procedure.No further action required.This assessment is based on information available at the time of the investigation.Pictures were returned for evaluation.Analysis of the pictures is in progress.A supplemental report will be filed when this analysis is complete.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.
• Manufacturer Contact: 10 north high street; west chester, PA 19380
• MDR Report Key: 4602871
• MDR Text Key: 16075664
• Report Number: 2523595-2015-00062
• 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: 02/18/2015

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: 11/01/2016
• Device Lot Number: C146-KIT
• Other Device ID Number: 107050300100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 80