MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem Tingling (2171)

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 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 28-jun-2014.As part of the review, it was determined that the instrument's last service was on 21-dec-2018.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Based on an assessment of the complaint description, the customer did acknowledge that the tingling that the patient experienced was due to the nurses forgetting to hang the calcium for the patient.The customer stated that tingling was a common reaction when acda is used as an anticoagulant and that calcium is usually given along side the acda in order to counterbalance a possible citrate reaction.The customer reported that when the nurses hung the two grams of calcium the patient's tingling stopped and the patient's treatment was completed without any further issues.The most likely cause for this adverse event was the fact that the nurses did not provide the patient with calcium while acda was being used as the anticoagulant for the patient's treatment procedure.Trends were reviewed for complaint category, tingling.No trends were detected for this complaint category.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: tingling.Mc (b)(4).(b)(6), 03/06/2019.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced tingling during a treatment procedure.The customer stated that this was their first time treating a patient who had heparin induced thrombocytopenia.The customer reported that due to this affliction they could not use heparin as the anticoagulant for this patient's treatment procedure.The customer stated that they used acda at a 10:1 ratio as the anticoagulant for this patient's treatment procedure.The customer reported that the tingling that was experienced by the patient was due to the acda anticoagulant.The customer stated that tingling is a common reaction when acda is used as an anticoagulant and that calcium is usually given alongside the acda in order to counterbalance a possible citrate reaction.The customer reported that the nurses who were performing this patient's treatment procedure forgot to hang the patient's calcium.The customer stated that when the patient started to complain of tingling, the nurses hung two grams of calcium and the patient's tingling stopped.The customer reported that there were no further issues with the patient's treatment procedure.The customer stated that the patient's treatment procedure was completed as normal with both blood and treated cells returned to the patient.The customer reported that the patient was in stable condition.No product was returned for investigation.

• 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: 8397074
• MDR Text Key: 138082439
• Report Number: 2523595-2019-00030
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2019

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2013
• 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: 54 YR