MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the saline solution that was given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.The instrument has been located at the customer's site since (b)(6) 2017.No service was requested by the customer for this adverse event at the time of the event.On (b)(6) 2017 while on a site visit, a therakos service engineer discovered that this instrument's bowl optic sensor, which controls the buffy coat collection, was outside of its threshold.A service order, (b)(4), was initiated and the bowl optic sensor was replaced that same day.A water treatment and the system checkout procedure were also successfully performed.Trends were reviewed for complaint categories, equipment performance, alarm #16: collect pressure, alarm #17: return pressure, and hypotension.No trends were detected for these complaint categories.The instrument's smartcard was returned for investigation.Based on a review of the smartcard data it was determined that prime was successfully completed.An alarm #7: blood leak (centrifuge chamber) alarm then occurred which is a sign that the customer was testing the leak sensor prior to the start of collection.The collection was started in single needle mode.An alarm #16: collect pressure alarm occurred and the purging air phase of the treatment procedure was completed after 216 ml of whole blood processed.Seven more alarm #16: collect pressure alarms occurred and the limit for the collect pressure was reduced to -125 mmhg after 581 ml of whole blood processed.Five alarm #17: return pressure alarms occurred for pressure below the lower return limit.The customer reduced the target whole blood processed volume to 823 ml and two more alarm #17: return pressure alarms occurred for pressure below the lower return limit.The operator ended treatment after 1059 ml of whole blood processed without the buffy coat being completed.The return bag volume was 323 ml when the customer elected to end the treatment.The data showed that the instrument was regularly returning the volume in the return bag to the patient as expected before the customer pressed the end treatment button.The last indication of blood return from the return bag to the patient was just after the customer reduced the target whole blood processed volume as expected.There was no further return of blood to the patient after that change as the instrument is programmed to expect that the buffy coat phase would complete.The volume in the return bag kept increasing after the whole blood processed volume was changed since the buffy coat phase was never completed.The alarm #16: collect pressure and alarm #17: return pressure alarms that occurred during the treatment procedure are an indication that there could have possibly been an access issue with this patient.This treatment procedure was performed using a peripheral access instead of the patient's port access which had been used in past treatment procedures.Since the instrument pauses after each pressure alarm, this could have caused the delay in the buffy coat collection.In addition, the bowl optic sensor for this instrument was found to be outside of its threshold and was replaced.Thus based on the available information the exact root cause for this event could not be determined.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event term: hypotension.(b)(4).

Event Description

The customer reported that a patient experienced hypotension during a treatment procedure.The customer stated that the patient was undergoing a single needle mode treatment using a peripheral access.The customer reported that the patient's previous treatment procedures had been successfully completed using the patient's port access.The customer stated that during the treatment procedure several alarm #16: collect pressure alarms occurred and they decided to reduce the whole blood processed volume in order to go to an early buffy coat.The customer reported that the new whole blood processed volume was set at 823 ml and the instrument initiated buffy coat collection.However, the customer stated that after 1059 ml of whole blood processed, the buffy coat collection was still not completed and there was 304 ml in the return bag.The customer reported that they decided to end the treatment due to the high extra-corporeal volume that this was causing.The customer stated that the treatment was ended with blood returned to the patient via the instrument.The customer reported that the patient experienced hypotension during the treatment procedure.The customer stated that the patient's pre-blood pressure was 130/65 mmhg and that their blood pressure had dropped to 80/50 mmhg during the treatment procedure.The customer reported that the patient was administered 500 ml of a saline solution as compensation volume however no transfusion was needed as the blood was returned to the patient via the instrument.The customer stated that the patient was in stable condition.The smartcard was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; 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: 7181439
• MDR Text Key: 96934773
• Report Number: 2523595-2018-00011
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)160524
• 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: 01/10/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• 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: 15 YR