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

Lot Number B109/345

Device Problems Leak/Splash (1354); Loss of Power (1475); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

Customer reported a leak in the centrifuge chamber.The leak occurred at end of the treatment when collecting buffy coat.Customer stated that the machine stopped after alarm #18: sys pressure occurred and the customer observed blood running out of the centrifuge chamber.No alarm #7: blood leak? (centrifuge chamber), occurred.Customer could not find the position of the leak.The treatment was aborted.Pt platelet count 118000.Ac: heparin 15000 iu in 500ml saline, ratio 10:1.Access dnm/pvc 20g.Pt was in stable condition.Pt was provided with one 500 ml ringer infusion after treatment.Customer asked for service to check and clean the machine.Service order (b)(4) was generated.Photos and the smart card data were sent for investigation.

Manufacturer Narrative

A review of lot b109 was performed and there was one non-conformance related to this event type, (b)(4), for drive tube delamination.Mfg procedure bounds the failure by add'l testing of procedural kits where the failure occurred.This lot met release requirements.Trends were reviewed for complaint categories, alarm #18: system pressure and drive tube leak/break.No trend was detected for alarm #18.A downward trend was observed for drive tube leak/break.Alarm #18 was investigated through capa (b)(4), which has been closed.Drive tube breaks were investigated through capa (b)(4), which has been closed, and capa (b)(4).Service order (b)(4) completed: service engineer cleaned remaining blood under the cover.The blood leak most probably originated from the bottom of the bowl.The leak detector sensor is ok.No further action required.The assessment is based on info available at the time of the investigation.Eval of the photograph-hs and smart card data is still in progress at the time of this report.A supplemental report will be filed when this eval is complete.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYS
• 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: 4361487
• MDR Text Key: 5289370
• Report Number: 2523595-2014-00327
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/03/2014

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: 03/01/2015
• Device Lot Number: B109/345
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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: 52 YR
• Patient Weight: 78