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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot g378 was conducted.There were no non-conformance related to the complaint.This lot met all release requirements.A review of kit lot g378 for the reported issue shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a tubing leak during the treatment procedure.The customer stated they noticed a leak coming from the tubing connected to the hematocrit cuvette.The customer reported approximately 257 ml of whole blood was processed at the time of the leak.The customer aborted the procedure and returned blood to the patient.The customer stated the patient was stable.The customer has returned the kit for investigation.

Manufacturer Narrative

The complaint kit and smart card were returned for investigation.A review of the smart card data showed prime was completed without incident and the treatment proceeded until 207 ml of whole blood was processed.Examination of the received kit verified the leak as blood was seen between the tubing and y-connector in the pump tubing organizer (pto).The received kit was pressure tested and verified a leak at the yellow striped tubing to y-connector.The cause of the leak was determined to be a weak solvent bond joint between the y-connector and yellow striped tubing.The root cause is a manufacturing operator error during the tube bonding process.Retraining has been completed for all bonding operators.No further action is required at this time.This investigation is now complete.This case is reportable as a mdr due to the reportable malfunction pump tubing organizer (pto) leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.Mc: (b)(4).P.T.06/18/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8672202
• MDR Text Key: 147568001
• Report Number: 2523595-2019-00061
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G378(17)201001
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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 Expiration Date: 10/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 83