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

Catalog Number CELLEX

Device Problems Insufficient Information (3190); Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Chest Pain (1776); Dyspnea (1816); Headache (1880); Nausea (1970); Blurred Vision (2137); Paresthesia (4421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and also due to the medical intervention of the hydromorphone, ringer's lactate, and esomeprazole that were provided 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.The distributor performs all of the service for this instrument and maintains the service history record.Trends were reviewed for complaint categories, alarm #53: return line air detected, chest pain, dyspnea, headache, blurred vision, nausea, paresthesia, air embolism, and atelectasis.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned smart card is still in process.A final report will be filed when the analysis is complete.Adverse event terms: chest pain, dyspnea, headache, blurred vision, nausea, paresthesia, air embolism, and appropriate term / code not available: atelectasis.(b)(4).(b)(6) 2023.

Event Description

The distributor reported that an extracorporeal photopheresis (ecp) patient experienced chest pain, dyspnea, blurred vision, headache, nausea, paresthesia, and a possible air embolism during their ecp treatment procedure.The distributor reported that several alarm #53: return line air detected alarms occurred during the patient's ecp treatment procedure, but they were able to continue with the patient's ecp treatment procedure.The distributor stated that near the end of the patient's ecp treatment procedure when the cellex instrument was returning the last of the return bag contents to the patient, the patient claimed that she detected air in the instrument's return line.The distributor reported that the patient then "manually closed their iv" as they began to experience dyspnea.The distributor stated that the patient contacted a nurse's aide who then stopped the patient's ecp treatment procedure.The distributor reported that the patient then began to experience chest pain, dyspnea, blurred vision, headache, nausea, and tingling in both their feet and hands.The distributor stated that the on-call physician was notified, and the patient was sent to the emergency room due to a suspected air embolism.The distributor reported that the patient underwent clinical laboratory tests while in the emergency room.The distributor stated that the patient was then admitted to the hospital for a chest x-ray and ct scans.The distributor reported that while in the hospital the patient received hydromorphone (0.2 mg every 8 hours intravenously), ringer's lactate (100 ml/hour intravenously) and esomeprazole (40 mg tablet every 24 hours).The distributor stated that the patient's clinical laboratory tests, chest x-ray, and ct scans did not confirm an air embolism.The distributor reported that the hospital was unable to provide a diagnosis for the patient's adverse events once the air embolism had been ruled out.The distributor stated that while the patient's ct scan did indicate baseline basal atelectasis, the hospital did not believe that the patient's ecp treatment procedure could have caused or contributed to the patient's baseline basal atelectasis.The distributor reported that the hospital did not believe that the patient's underlying condition could have caused or contributed to the patient's baseline basal atelectasis.The distributor stated that the patient was discharged from the hospital the following day on (b)(6) 2023 with respiratory incentive recommended.The distributor reported that due to the evidence of baseline basal atelectasis, the hospital recommended that the patient use an incentive spirometer.The distributor stated that the patient was now in stable condition and continuing with their monthly ecp treatment procedures.The distributor reported that the patient had undergone additional ecp treatment procedures on (b)(6) 2023 and (b)(6) 2023 without any complications.On (b)(6) 2023, a therakos clinical specialist (css) spoke with the distributor's cellex trainer who confirmed that the operator had performed inappropriate troubleshooting for the alarm #53: return line air detected alarms that had occurred during the patient's ecp treatment procedure.The trainer reported that the operator had swapped the cellex kit's return line with the saline line in the instrument's return line air detector in order to bypass the alarm #53: return line air detected alarm and continue with the patient's ecp treatment procedure.The trainer stated that the operator claimed that they then quickly put the return line back into the return line's air detector again once the alarms cleared.The trainer reported that the operator stated that they did not see any air going back to the patient.The trainer stated that they explained the risk of such inappropriate troubleshooting to the operator and then re-trained the operator on the correct troubleshooting steps for an alarm #53: return line air detected alarm.The customer returned the instrument's smart card for investigation.

Manufacturer Narrative

The smart card data was reviewed.The smart card data indicated that prime was successfully completed and then the primed kit sat on the cellex instrument for 15 hours and 9 minutes.The instrument's power was cycled the following day and an alarm #53: return line air detected alarm immediately occurred with the primed kit.The operator was able to bypass the alarm and connect the patient to the instrument.Blood collection began in single needle mode and alarm #53: return line air detected alarms occurred until 69mls of whole blood processed.The customer was able to bypass the alarms and continue with the patient's treatment.After 137mls of whole blood processed alarm #16: collect pressure and alarm #17: return pressure alarms began to occur.The instrument's collect and return pressure values were similar when most of these alarms occurred, likely suggesting an issue with either the patient's access or an obstruction within the kit.Buffy coat collection began after 1431mls of whole blood had been processed.Alarm #16: collect pressure and alarm #17: return pressure alarms occurred during buffy coat collection.Buffy coat collection ended after 102ml of buffy coat had been collected.Photoactivation was completed and the treatment continued until the abort button was pressed with 0ml left in the return bag.The smart card data confirmed the occurrence of multiple alarm #53: return line air detected alarms during the treatment which was completed.The root cause for the alarm #53: return line air detected alarms and the patient's chest pain, dyspnea, headache, blurred vision, nausea, paresthesia, air embolism, and atelectasis could not be determined based on the smart card data.It is unclear if the primed kit sitting on the instrument for 15 hours and 9 minutes between prime and patient treatment played a part in the instrument's alarm #53: return line air detected alarms, though the alarms occurred immediately upon cycling the instrument's power after this long standby time.Per the cellex operator's manual section 5-8, you may turn off the power after prime to relocate the instrument.While there is no time limit for power off, mallinckrodt recommends that the pending treatment be initiated within four hours.The distributor's cellex trainer also confirmed that the operator had performed inappropriate troubleshooting for the alarm #53: return line air detected alarms.The trainer reported that the operator had swapped the cellex kit's return line with the saline line in the instrument's return line air detector in order to bypass the alarm #53: return line air detected alarms and continue with the patient's ecp treatment procedure.The trainer stated that the operator claimed that they then quickly put the return line back into the return line's air detector again once the alarms cleared.The trainer reported that the operator stated that they did not see any air going back to the patient.The trainer stated that they explained the risk of such inappropriate troubleshooting to the operator and then re-trained the operator on the correct troubleshooting steps for an alarm #53: return line air detected alarm.Per the cellex operator's manual section 6-58, correcting alarms, the labeled troubleshooting steps for an alarm #53: return line air detected alarm are as follows: 1.Press mute to silence the alarm.2.Remove air from the return line.3.Check the connections to determine the possible source of air.4.Press reset.5.Press start to continue the treatment.6.If the alarm continues, contact mallinckrodt for further assistance.Note: · first disconnect your patient and then use a saline bolus to flush any air detected in the patient return line.Do not continue returning until the source of the air has been documented and removed.No further action is required at this time.This investigation is now complete.(b)(4).S.K.22-feb-2024.

• 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: 18330293
• MDR Text Key: 330554270
• Report Number: 3013428851-2023-00080
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170127
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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: 11/16/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 54 KG