MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Complete Blockage (1094); Device Displays Incorrect Message (2591)

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

Event Date 05/19/2017

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 clot in the return line.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.The instrument was considered but was found to be within specifications so a mdr will not be filed against the instrument.A batch record review of kit lot e230 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e230 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, clot observed and alarm #59: a/c pump (#5) error.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report clot observed and an alarm #59: a/c pump (#5) error alarm.The customer stated that the alarm #59: a/c pump (#5) error alarm occurred during prime and again during the treatment.The customer reported that they noticed some clots in both the centrifuge bowl and in the return line, so they decided to stop the treatment after 320 ml of whole blood processed.The customer stated that the treatment was aborted with no return of blood/products to the patient.The customer reported that they did not know if any clots were returned to the patient.The customer stated that the patient was in stable condition and was not impacted by the incident.The customer reported that they used heparin to prime the kit and then switched to acd-a for the treatment.The kit was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6642014
• MDR Text Key: 77789135
• Report Number: 2523595-2017-00108
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 06/14/2017

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: 12/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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: 63 YR
• Patient Weight: 79