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

Lot Number D302 - KIT

Device Problems Vibration (1674); Output below Specifications (3004)

Patient Problem Tingling (2171)

Event Date 03/31/2015

Event Type  Injury  

Event Description

Clinical services educator reported the following event that happened while she was on site on (b)(6).(b)(6) patient on crrt, double lumen apheresis catheter for access.After blood prime, patient was to receive 1l whole blood processed.At finish of blood prime, machine had processed 269ml.Target was 1269 in order to process 1l goal.Fluid balance was (-) 180; attempted to keep patient there throughout the procedure in order to maintain isovolemic state.Calcium gi running.At approximately 30 minutes into the procedure, patient complained of tingling lips and bed vibrating.Machine paused.Calcium level drawn, results 0.55.No protocol was available for this low level of calcium.Md ordered calcium bolus; calcium drip was increased.When symptoms subsided, the procedure was continued.After processing 770 ml of 1l target whole blood, blood pressure 73/42.Decision was made to go to early buffy coat.Afterward, there was an immediate recovery of blood pressure and the treatment was concluded without further incident.

Manufacturer Narrative

A review of lot d302 was performed and there were no nonconformances associated with this lot.This lot met release requirements.A review of complaint categories shows no trends for hypotension or for hypocalcemia.No capa has been initiated for these complaint categories.Based on the internal medical assessment, (b)(6) female with gvhd and liver failure was on crrt and ecp at the same time as per prescribing physician.Patient complained of tingling lips and bed vibrating.Calcium level was drawn and results were.55.A calcium bolus was given.Patient was on acda for anticoagulation.Patient developed a citrate reaction.Patient's blood pressure had gone down to 73/42 mmhg.After early buffy coat there was a recovery of blood pressure and there were no other issues.Both of the aes are procedural complications.Hypotension is a known ae.Uvadex was administered but the aes are not related.This case is serious and related to the procedure.There was no known device problem.This assessment is based on information available at the time of investigation.No product was returned for investigation; therefore it could not be determined if the product met specifications based solely on information provided by the customer.Complaints are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4701757
• MDR Text Key: 16455397
• Report Number: 2523595-2015-00096
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2015

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: Other
• Device Expiration Date: 01/01/2017
• Device Lot Number: D302 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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: 4 YR
• Patient Weight: 10