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

Lot Number C347-KIT

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/12/2014

Event Type  malfunction  

Event Description

The customer called to report a drive tube break at 863 ml of blood processed in dual needle mode.The customer stated that the rings form the drive tube 'disintegrated' and came off.The customer stated that early in the treatment, a red cell pump alarm occurred with a low interface due to the patient's high bilirubin.The customer lowered the bowl optic sensor incrementally to 100, and the interface was appropriate.The customer inquired about volume loss; and the clinical services specialist referenced technical bulletin #8 for approximate loss.The customer stated that the patient did not require medical intervention.The patient was transfused prior to the original treatment due to a hgb level of 8.9.The patient was reported to be in stable condition.The patient was treated on a different instrument immediately following the drive tube break.The customer sent an email on (b)(6) 2014 which stated that after 800 cc of blood had been processed, a blood leak alarm was observed.The customer opened the door and found the drive tube dangling and out of th e clips that holds the ball bearings.The customer wrote that the drive tube was torn up at the base of the drive tube; however, the clips were found to be closed.The customer wrote that they opened the clips to make sure that the clips were not defective.The customer wanted to clarify that the clips were closed when the drive tube broke.The customer also stated that they found the disintegrated ball bearings on the floor of the compartment in three pieces.The customer swore that she installed the kit properly; however, the customer did not disregard the fact that it could be human error.The kit was not returned for evaluation; however, the customer sent pictures for evaluation.Service order, (b)(4) was generated.

Manufacturer Narrative

A batch record review of lot c347 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, alarm #45: red blood cell pump alarm, drive tube leak/break, and alarm #7: blood leak (centrifuge chamber).An upward trend was detected for complaint category, alarm #45: red blood cell pump alarm.A downward trend was detected for complaint category, drive tube leak/break.No trend was detected for complaint category, alarm #7; blood leak (centrifuge chamber).Alarm #45: red blood cell pump alarm was investigated through capa (b)(4).Capa (b)(4) was closed.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 found the centrifuge wouldn't rotate and that the air pressure was too low.He found that the f5 blew due to the drive tube break.He verified that the drive tube rotated and that the air pressure was in spec.He performed the system checkout.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 returned pictures is in progress.A supplemental report will be filed when this analysis is complete.Meddra: lt-device malfunction-(b)(4).Kit unique device identifier: (b)(4).Ttqms: (b)(4).Rr: (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.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, ste. 140; bridgewater, NJ 08807
• MDR Report Key: 4373680
• MDR Text Key: 5285221
• Report Number: 2523595-2014-00345
• 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: 12/12/2014

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: 09/01/2016
• Device Lot Number: C347-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 33 YR
• Patient Weight: 83