MAUDE Adverse Event Report: THERAKOS, INC. CELLEX; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number CELLEXUSA

Device Problems Problem with Software Installation (3013); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

A patient was receiving a photopheresis procedure in our apheresis department.This is an outpatient procedure, however the patient was a planned admission to another unit for unrelated tests.This photopheresis procedure consists of removing blood from the patient via the machine, treating it through a light source, and then administering the treated blood product back to the patient.During the procedure the machine malfunctioned throwing an error code of 142 and the procedure was unable to be completed.The nurses (rn¿s) were able to switch to the second machine to continue the procedure.Unfortunately, this machine also malfunctioned by generating a similar error code before the end of the procedure.Since we only have 2 machines, the rns were unable to continue with the procedure.The product was removed from the machine and was manually administered back to the patient.This transfer caused a loss of blood product and the patient did not receive the anticipated amount.After 1425 ml whole blood processed.Rn followed instruction to power off and power on machine and then call customer service rep.Rep instructed to give back patient's blood back and take machine out of service.Both of these machines went through a software upgrade in early (b)(6) of this year by therakos mallinckrodt.Therakos mallinckrodt was contacted immediately following the first and second malfunction.The in-house biomed followed up with the therakos mallinckrodt field serve rep the next morning.During the conversation, it was disclosed that because of the cellx software upgrade to v5.4 from v3.0 created tighter range tolerances for the sensors within the device.He stated that within the first 2-3 months of a software upgrade they would typically see these types of error codes.Both devices had generated error codes 142 (thermistor temperature delta >+- 3 degree celsius).Therakos mallinckrodt will be providing the parts for free with the service call thursday morning.Manufacturer response for photopheresis system, therakos cellex photopheresis system (per site reporter).Field service rep is coming on-site to evaluate the issue.Could be related to the recent software upgrade of the device the previous month.Software update from 3.0v to 5.4v.Tolerances for all the internal sensors become a tighter range.Rep suspected that this is typical to see these type of error codes in the months following a software change.

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 84 park rd; queensbury NY 12804
• MDR Report Key: 12922674
• MDR Text Key: 281857468
• Report Number: 12922674
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CELLEXUSA
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4745 DA
• Patient Sex: Female
• Patient Weight: 43 KG