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

Catalog Number CELLEX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2021

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 electrolyte infusion and calcium gluconate that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no instrument issue was alleged by the customer.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 (b)(6) 2016.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 2021.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 #19: fluid balance limit, malaise, hypotension, and hypocalcemia.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, low blood pressure/hypotension, and code not available: hypocalcemia.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced malaise, hypotension and hypocalcemia during an ecp treatment procedure.The customer stated that at the end of the patient's ecp treatment procedure, an alarm # 19: fluid balance limit alarm occurred.The customer reported that they had administered more than the usual amount of saline to the patient due to the patient becoming hypotensive and feeling unwell at around 200ml of whole blood processed.The customer stated that the patient's systolic blood pressure at the start of their ecp treatment procedure was 110 and it had dropped to 90 at around 200ml of whole blood processed.The customer reported that they then administered a saline bolus of 100ml plus 500ml of an electrolyte infusion to the patient.The customer also stated that the patient had experienced a minor citrate toxicity reaction during their ecp treatment procedure.The customer reported that acd-a + 10 000iu heparin at a ratio of 8:1 was used as the anticoagulant for the patient's ecp treatment procedure.The customer stated that the patient's platelet count prior to their ecp treatment procedure was 842 000.The customer reported that an infusion of calcium gluconate was administered to the patient for their hypocalcemia.The customer stated that the patient quickly recovered from their malaise, hypotension, and hypocalcemia and they resumed the patient's ecp treatment procedure.The customer reported that the patient remained stable throughout the rest of their ecp treatment procedure.The customer stated that the patient's ecp treatment procedure was completed with both blood and treated cells returned to the patient.The customer reported that the patient's underlying condition could have caused or contributed to the incident.The customer stated that there might be a relationship with the patient's ecp treatment procedure and the incident.The customer reported that she could not exclude the patient's ecp treatment procedure as possibly causing or contributing to the incident due to the extracorporeal blood exchange that occurs during ecp treatment procedures.The customer stated that this patient has undergone ecp treatment procedures for several years now and usually tolerates their ecp treatment procedures well.The customer reported that the patient will continue with their ecp treatment procedures.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; blanchardstown, dublin ; EI
• 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 ; shelbourne building; 53 frontage rd suite 300; hampton, NJ 08827
• MDR Report Key: 13029094
• MDR Text Key: 286457087
• Report Number: 2523595-2021-00113
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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 Sex: Male
• Patient Weight: 100 KG