MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Device Displays Incorrect Message (2591)

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

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f221 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f221 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #56: red cell pump (#2) error and tubing leak.No trends were detected for these complaint categories.A photo analysis was conducted for this complaint.A review of the photos confirmed the leak.An evaluation of the photos found evidence of a leak within the yellow striped tubing when the tubing is squeezed.The review of the photos indicated that there was a defect on the tubing which could have caused the leak.However, it is not clear from the photos what kind of damage was present on the tubing.Thus the root cause for the leak could not be determined based on the available information.The device history record (dhr) review did not result in any related nonconformances and this kit lot had passed all lot release testing.A material trace of the yellow striped tubing used to build this kit lot also did not find any related nonconformances.All kits under go an occlusions/leak test before they are released.This test identifies any occluded/ leaking tubing or other components within the kit.Only the kits that have passed this test are released for use.As this kit had passed all lot release testing, the damage seen on the tubing is most likely not manufacturing related.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.(b)(4).

Event Description

The customer called to report an alarm #56: red cell pump (#2) error alarm and a tubing leak which occurred during a treatment procedure.The customer stated that the alarm #56: red cell pump (#2) error alarm occurred during the purging air phase of the treatment after 156ml of whole blood processed.The customer reported that they checked the kit and found a small hole in the yellow stripped tubing which runs between the centrifuge and the red cell pump.The customer stated that they noticed a leak originating from this hole, so they disconnected the patient from the instrument.The customer reported that the treatment was aborted with no return of blood/products to the patient.The customer stated that the patient was in stable condition.The customer reported that the patient was going to be treated with a new kit.The customer stated that the affected kit was no longer available and thus will not be returned for investigation.Photos were submitted for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 6766060
• MDR Text Key: 82294268
• Report Number: 2523595-2017-00141
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/03/2017

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: Nurse
• Device Expiration Date: 05/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• 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: 47 YR
• Patient Weight: 66