MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM; CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM,

Catalog Number CELLEX

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Burning Sensation (2146); Malaise (2359)

Event Date 10/12/2023

Event Type  Injury  

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced malaise, a burning sensation, and hypotension during their ecp treatment procedure.The customer stated that citrate at a ratio of 10:1 was used as the anticoagulant in the patient's ecp treatment procedure.The customer reported that the cellex kit (kit) primed without any alarms and they then connected the patient.The customer stated that after less than 500mls of whole blood processed the patient began to complain of a burning sensation at their iv site.The customer reported that they checked the patient's iv site, and since it looked okay, they continued with the patient's ecp treatment procedure.The customer stated that the patient then complained of feeling unwell and they noticed that the patient's blood pressure had dropped.The customer could not provide the patient's blood pressure valves.The customer reported that they then gave the patient a 100ml bolus through the cellex instrument of what they thought was saline.The customer stated the patient's condition did not improve, so they gave another 100ml bolus to the patient.The customer reported that when the patient's condition still did not improve, they stopped the patient's ecp treatment procedure, and this is when they noticed that they had swapped the kit's anticoagulant and saline lines during the kit set up.The customer stated that the patient had received 200mls of citrate anticoagulant instead of saline.The customer reported that the patient's ecp treatment procedure was then aborted with no blood returned to the patient.The customer stated that the patient was then administered one gram of calcium along with an iv bolus of 500mls of normal saline.The customer reported that the patient was also given tums prior to being discharged.The customer stated that the patient's blood pressure was 135/84mmhg prior to being discharged.The customer reported that the patient was stable at time of discharge and that the patient would be continuing with their ecp treatment procedures.No product was returned for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the calcium, iv normal saline and tums that were provided 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 for investigation.The instrument has been located at the customer's site since (b)(6) 2012.The customer has their own biomed who services this device and maintains the device's service history records.The most likely root cause for the patient's adverse events is use error as the customer acknowledged that they swapped the kit's anticoagulant and saline lines during the kit set up.Due to this use error, the patient had received 200ml of the anticoagulant, citrate, instead of saline.The kit's saline and anticoagulant lines are color coded for easy recognition.Per the cellex operator's manual section 3-33, saline source line & spike chamber: this saline source line connects the saline solution bag and the pump tubing organizer.It has a (white) spike chamber and clear tubing.Anticoagulant (a/c) source line & spike chamber: the a/c source line connects the anticoagulant solution bag and the pump tubing organizer.It has an (orange) spike chamber and is identified with an (orange) stripe on the tubing.In addition, section 3-16 of the cellex operator's manual, placement of saline and anticoagulant bags provides a photograph (figure 3-19) depicting the proper spiking of the saline and anticoagulant bags.This section also states caution: correct attachment of the saline and anticoagulant bags to the correct fluid spike is essential.Incorrect attachment may lead to clotting in the procedural kit, patient blood loss, and a failed treatment.Trends were reviewed for complaint categories, ac and saline spikes swapped, malaise, burning sensation, and hypotension.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: malaise, burning sensation, and low blood pressure / hypotension.(b)(4).(b)(6) 2023.

• Brand Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM,
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer (Section G): MACK MOLDING COMPANY; 608 warm brook rd; arlington VT 05250
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 18017095
• MDR Text Key: 326677701
• Report Number: 3013428851-2023-00074
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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: 10/26/2023

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2012
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG