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 Blood Loss (2597)

Event Date 08/22/2017

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.A batch record review of kit lot f123 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f123 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #17: return pressure and clot observed.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.

Event Description

The customer called to report alarm #17: return pressure alarms and clots.The customer stated that an alarm #17: return pressure alarm occurred while returning the blood to the patient after 1508ml of whole blood processed.The customer reported that the treatment was in double needle mode and the instrument's return pressure was reading 0mmhg.The customer stated that the return bag's volume was 507ml and that they had already reduced the return rate.The customer reported that the return rate was now less than the collect rate.The customer stated that they then switched to single needle mode in order to return the return bag volume to the patient.However, the customer reported that the alarm #17: return pressure alarm still posted.The customer stated that they flushed the return line and found a clot.The customer reported that there were also clots in the centrifuge bowl.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient was in good condition and did not require any medical intervention.The customer stated that the patient did not need to stay any longer than planned in the hospital.The customer reported that the anticoagulant, acd-a, was used during the treatment at a ratio of 12:1.The kit was not returned 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: 6878074
• MDR Text Key: 87744112
• Report Number: 2523595-2017-00172
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/19/2017

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: 06/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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: 62 YR
• Patient Weight: 78