MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Misassembly by Users (3133)

Patient Problems Nausea (1970); Malaise (2359); No Code Available (3191)

Event Date 10/08/2018

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 that was provided to the patient.Since this event is associated with the kit, this mdr will be against the kit.Kit lot g244 was reviewed.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g244 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure, equipment performance, bags/lines swapped - saline and anticoagulant, nausea, malaise, and altered taste.No trends were detected for these complaint categories.Even though no product return was received for this complaint, the customer acknowledged that the root cause for this complaint was use error.The customer stated that the kit's anticoagulant and saline lines and been inadvertently switched by the user at the time of kit setup.The anticoagulant was plugged into the saline line and saline into the anticoagulant line.This incorrect kit setup then lead to the patient's adverse events.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: nausea, malaise, and other: altered taste.Mc (b)(4).(b)(6) 10/17/2018.

Event Description

The customer called to report that a patient experienced general malaise, nausea and altered taste while undergoing an extracorporeal photopheresis (ecp) treatment procedure.The customer stated that an alarm 18: system pressure alarm occurred after 780ml of whole blood processed.The customer reported that both the anticoagulant and return pumps on the instrument were not turning properly when the alarm 18: system pressure alarm occurred.The customer stated that the patient then complained of general malaise, nausea and altered taste.The customer reported that they aborted the treatment with no blood returned to the patient.The customer stated that once they removed the kit from the instrument, both the anticoagulant and return pumps could be manually turned without any problem.The customer reported that they checked the kit and found that the customer provided saline and anticoagulant bags were switched.The customer stated that the anticoagulant, acd-a at a ratio of 1:10, was spiked into the saline line and the saline into the anticoagulant line.The customer reported that they then checked the kit's centrifuge bowl and return bag.The customer stated that they saw aggregates inside the kit's centrifuge bowl and the blood in the kit's return bag looked gelatinous.The customer reported that the patient was treated with a calcium injection and experienced no further symptoms after the injection.The customer stated that the patient was fine after the calcium injection and went home.The customer reported that a colleague had initially set up the kit.No product was returned for investigation as the kit had already been discarded.

• 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: 7973617
• MDR Text Key: 123962752
• Report Number: 2523595-2018-00162
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: G244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2018
• 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: 39 YR
• Patient Weight: 69