MAUDE Adverse Event Report: HARMAC MEDICAL PRODUCTS THERAKOS CELLEX PHOTOPHERESIS SYSTE,

Lot Number C303-KIT

Device Problems Crack (1135); Leak/Splash (1354); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

Customer called to report a drive tube leak that occurred during treatment.Customer reported a drive tube leak occurred during a cellex single needle mode treatment, at about 600 to 800 ml whole blood processed.Customer stated there was an unusual clicking noise, just before an "alarm #7: blood leak? (centrifuge chamber)" occurred.Treatment was then aborted with none of the blood in the kit at that time returned to the pt.Customer stated the blood leak in the centrifuge came from a slit in the drive tube, the drive tube was not severed, and the drive tube bearings were still in both bearing retainers.Customer reported the centrifuge leak sensor strip did not appear to have been damaged.Customer reported the pt was stable.Customer returned centrifuge bowl, drive tube and the smart card for investigation; also some photos were provided for eval.Service order (b)(4) was dispatched to clean and check the instrument.

Manufacturer Narrative

Batch record review of lot c303 was conducted.There were no non conformances associated with this type of failure for this lot.Lot met release requirements.Trends have been reviewed for this complaint category and no trend has been detected.Service order (b)(4) completed: service engineer cleaned interior and frame arm.Cleaned latch and clamp assembly.Cleaned entire area throughly and performed system, checkout test.The centrifuge bowl, drive tube and the smart card were received for investigation; also some photos were used for eval.The photos show a leak in the drive tube, therefore, this complaint is valid.It is evident that the leak was caused by the top bearing stop delaminating from the drive tube.The delamination of the bearing stop in this scenario would have been caused by the portion of the bearing stop being unbonded to the drive tube.Therakos capa (b)(4) and harmac (b)(4) have been opened to investigate the trapped gases occurring during the bearing stop molding process.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTE,
• Type of Device: CELLEX
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 abilet ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 3818477
• MDR Text Key: 19586219
• Report Number: 2523595-2014-00089
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/03/2014

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: Other
• Device Expiration Date: 01/01/2016
• Device Lot Number: C303-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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: 61 YR