MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359); Sweating (2444); Pallor (2468); No Information (3190)

Event Date 08/16/2017

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 iv fluids and transfusion that were given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.No service was requested by the customer for this adverse event.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since 30-aug-2011.As part of the review, it was determined that the instrument's last service was on 04-may-2017.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Trends were reviewed for complaint categories, alarm #16: collect pressure, alarm #17: return pressure, alarm #49: return bag - air detected, hypotension, malaise, other adverse event: pale, other adverse event: sweating, and other adverse event: cold.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.Adverse event terms: hypotension, malaise, pallor, sweating, and other: cold.(b)(4).

Event Description

The customer reported that while undergoing a double needle mode treatment, the patient bent both his arms.The customer stated that alarm #16: collect pressure and alarm #17: return pressure alarms then occurred.The customer reported that the alarms occurred during the buffy coat collection phase of the treatment.The customer stated that they then noticed that the patient was not feeling well, the patient was also pale, sweating, and felt cold.The customer reported that the patient's blood pressure had dropped to 80/40 and the patient's o2-saturation was at 94%.The customer stated that the patient was barely addressable for a short period of time.The customer reported that the treatment was paused and iv-fluids, saline and electrolytes, were administered to the patient.The customer stated that the decision was made to end the treatment with blood returned to the patient via the instrument.However, the customer reported that an alarm #49: return bag - air detected alarm then occurred along with a "pop-up message" on the instrument' monitor stating "is the return bag empty/not empty?".The customer stated that the return bag was not empty but the alarm could not be reset.The customer reported that the treatment was then aborted with manual return of the blood to the patient.The customer stated that the patient underwent an ecg in order to exclude any cardiac issues.The customer also reported that a blood count was taken.The customer stated that the patient recovered after the blood return and had stable parameters when he left the department.The customer reported that the patient returned the following day and received a blood transfusion.The customer stated that the patient's medications will be checked, especially their blood pressure medication.The customer reported that the patient's next treatment was planned in two weeks.No product was 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: 6867729
• MDR Text Key: 86255539
• Report Number: 2523595-2017-00171
• Device Sequence Number: 1
• Product Code: LNR
• 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: 09/14/2017

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: 08/16/2017
• Initial Date FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2011
• 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: 78 YR
• Patient Weight: 59