MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Thrombus (2101); Blood Loss (2597)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e218 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.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.(b)(4).Device not returned to manufacturer.

Event Description

The customer reported multiple alarm #17: return pressure alarms after 339 ml of whole blood processed.The customer stated that they decreased the return rate, but the alarm continued to occur.The customer reported that they flushed the patient's access using a 10 ml saline syringe, however the alarm continued to occur.The customer stated that they then reduced the return rate to 15 ml/min and increased the pressure allowance in the instrument's setup, but the alarm continued to occur.The customer reported that they could see clots in the return bag.The customer stated that 15 000 ie heparin in 500 ml saline was the anticoagulant ratio that was used for this treatment.The customer reported that the treatment was aborted with no return of blood/products to the patient.The customer stated that the approximate blood loss was 338 ml.The customer reported that the patient received 500 ml of saline after the treatment and a blood transfusion was planned.On (b)(6) 2016, the customer confirmed that the patient did receive an unplanned transfusion of two units of red blood cells.The customer stated that the patient had received a treatment the following day, and that the treatment was completed without any issues.The customer reported that the patient was in stable condition.The instrument 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: 6211569
• MDR Text Key: 63477858
• Report Number: 2523595-2016-00285
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)160706
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 73