MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Break (1069); Leak/Splash (1354)

Patient Problems Anemia (1706); No Code Available (3191)

Event Date 01/03/2019

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 transfusion that was provided to the patient.Since this adverse event is associated with the kit malfunction, this mdr will be against the kit.Kit lot g365 was reviewed.There were no nonconformances related to the complaint.This lot met all release requirements.A review of kit lot g365 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break, low hematocrit, and low hemoglobin.No trends were detected for these complaint categories.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: anemia and no code available: low hematocrit (b)(4).(b)(6), 02/01/2019.

Event Description

The customer called to report a centrifuge bowl leak/break that occurred during a treatment procedure.The customer stated that there were no alarms during the treatment procedure.The customer reported that the centrifuge bowl shattered at approximately 400ml of whole blood processed.The customer stated that the treatment was then aborted with no blood or treated cell returned to the patient.The customer reported that the patient received a blood transfusion in the hospital unit due to a drop in both the patient's hematocrit and hemoglobin levels.The customer stated that the patient went home after their blood transfusion was completed.The customer reported that the patient was in stable condition.The kit was not returned for investigation as it had already been discarded.This mdr is for the adverse events of low hemoglobin and low hematocrit.The reportable malfunction of the centrifuge bowl leak/break was reported under (b)(4).

• 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: 8299412
• MDR Text Key: 134863288
• Report Number: 2523595-2019-00014
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G365(17)200901
• 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: 02/01/2019

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 Expiration Date: 09/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2018
• 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: 53 YR