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

Lot Number C344-KIT

Device Problems Break (1069); Component Falling (1105); Leak/Splash (1354); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 01/23/2015

Event Type  malfunction  

Event Description

The customer reported a blood leak alarm that occurred when a treatment had reach about 150 to 200 ml whole blood processed.The treatment was aborted at that time and the blood in the kit was not returned to the patient.The customer reported that a crackling sound was heard shortly before the leak occurred.The customer reported that they found the drive tube had a crack or split between the two drive tube bearings.The lower bearing had broken apart, with the pieces of the bearing on the floor of the centrifuge.The customer stated the centrifuge leak sensor strip was not damaged.The patient was reported in stable condition, and the customer had already started a new ecp treatment for him.Service order, (b)(4), was generated to clean and check the instrument.The kit was returned for investigation.

Manufacturer Narrative

A batch record review of lot c344 was reviewed.There were no nonconformances related to this complaint.The lot met release requirements.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber), drive tube leak/break and noise.No trend was detected for these complaint categories.No capa was initiated for complaint categories, alarm #7: blood leak (centrifuge chamber) and noise.Drive tube leak/break was investigated through capa (b)(4) and capa (b)(4).Capa (b)(4) was closed.Service order, (b)(4), feedback; the service technician finished the centrifuge cleanup.The technician also replaced the lower bearing clip due to channel wear from bearing falling apart in the clip.He then performed the system checkout procedure.No further action is required.Product return analysis feedback; the kit and smart card were returned for analysis.The blood leak (centrifuge) alarm was verified upon review of the smart card data.During the analysis of the returned components, the reported leak was confirmed in the red cell outlet line below the lower bearing stop of the drive tube.The analysis also determined that evidence suggests that the leak was caused by the improper installation of the lower drive tube bearing into the instrument.No faults were identified in the kit during the analysis that may have caused or contributed to the incident.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave
• Manufacturer Contact: 10 n high st; west chester, PA 19380
• MDR Report Key: 4528068
• MDR Text Key: 5357977
• Report Number: 2523595-2015-00039
• 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: 01/23/2015

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: 09/01/2016
• Device Lot Number: C344-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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: 56 YR
• Patient Weight: 104