MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Use of Device Problem (1670)

Patient Problems Nausea (1970); Tingling (2171); No Code Available (3191)

Event Date 12/12/2019

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 calcium gluconate perfusion and 0.9% saline that were provided to the patient.Since this event is associated with the kit, this mdr will be against the kit.No product was returned for investigation.Kit lot h135 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot h135 shows no trends.The root cause for this complaint has been determined to be use error as the customer has acknowledged that they made the mistake of connecting the saline and anticoagulant spikes to the wrong iv bags during kit set up.The saline spike was connected to the anticoagulant iv bag which allowed the patient to receive more anticoagulant than normal.Both the anticoagulant (a/c) and saline line are color coded for easy identification.The a/c line and associated spike are colored coded (green or orange), while the saline line and spike are clear.Section 3-32 of the operator's manual states "the a/c source line connects the anticoagulant solution bag and the pump tubing organizer.It has a spike chamber and is identified with a (green or orange) stripe on the tubing." in addition, in section 4-23 of the operator's manual entitled preparing and hanging saline and anticoagulant solutions it states, "spike the anticoagulant solution with the spike attached to the (green or orange striped) line.Hang the anticoagulant bag on the lower right side of the instrument (as you face it) using the back hook.Spike a 500 ml bag of 0.9% normal saline with the spike attached to the clear line.Hang the saline bag on the lower right side of the instrument (as you face it) using the front hook." figure 4-26 in the operator's manual provides a color photo showing the proper placement and spiking of both the saline and a/c iv bags.A technical bulletin, technical bulletin #22: anticoagulant (a/c) spike and tubing color update, was also sent to all global customers in multiple languages in 2015 stating the anticoagulant spike and tubing in the therakos cellex system procedural kit may have either a white spike with green striped tubing or an orange spike with orange striped tubing.The a/c spike and tubing color change to all orange will be phased in during 2016.Trends were reviewed for complaint categories, bags/lines swapped: anticoagulant and saline lines, hypocalcemia, nausea, and paresthesia.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: no code available: hypocalcemia, nausea, and tingling.(b)(4).

Event Description

The customer reported by email that an extracorporeal photopheresis (ecp) patient experienced hypocalcemia, nausea, and paresthesia during a treatment procedure.The customer stated that at the very beginning of the patient's ecp treatment procedure, the patient exhibited signs of "major hypocalcemia".The customer reported that the patient complained of both nausea and paresthesia of the face.The customer reported that they instantly discovered that the kit's lines for both the saline 0.9% and anticoagulant (acd-a) iv bags had been accidentally inverted during set-up.The customer stated that the patient's ecp treatment procedure was immediately paused and the patient was administered a calcium gluconate perfusion along with 0.9% saline.The customer reported that the patient's clinical signs disappeared rapidly and the patient's ecg was normal.The customer stated that the patient's ecp treatment procedure was then aborted with no blood or treated cells returned to the patient.The customer reported that the patient's ecp treatment procedure was postponed till the next week.The customer stated that the patient has been treated several times since this incident without any issues and the patient is currently in good condition.The customer reported that there were no errors in regards to the line layout of the kit, instead they just made a "mistake" during the installation of the kit.The customer stated that they will now mark the kit's anticoagulant tubing with a fluorescent label and will verify the installation and setup of the kit with two different nurses.No product was returned for investigation as the kit had already been discarded by the customer.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 9656812
• MDR Text Key: 190810944
• Report Number: 2523595-2020-00020
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2020

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: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 02/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 54