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

Lot Number D134 - KIT

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

Patient Problems Erythema (1840); Headache (1880); High Blood Pressure/ Hypertension (1908); Skin Discoloration (2074); Patient Problem/Medical Problem (2688)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d134 was performed.There were no nonconformances related to this complaint.This lot met release requirements.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, hypertension, headache, and skin redness and no trends were detected.The smart card data was returned for analysis.Review of the smart card data confirms a treatment with a blood prime that was completed.The only alarms that occurred during this treatment were a number of collect pressure warnings.The analysis was unable to determine if there was an issue with the kit that caused or contributed to the raised blood pressure and the warm feeling that the patient experienced during photoactivation.No manufacturing related defects were confirmed during the evaluation and the kit lot passed all release testing.Based on internal medical assessment, (b)(6) female patient with uncontrolled blood pressure started to feel ill during photoactivation.From uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is serious, unrelated and unexpected to uvadex.The event happened before reinfusion of blood products with uvadex.This is not reportable from a drug perspective.From a device perspective, this event did not cause or contribute to a death or serious injury; and or the system did not cause or contribute to a death or serious injury nor malfunction in a way that would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.There is no device malfunction.The operator used acda as an anticoagulent.Per the operator's manual, heparin is to be utilized.Further, they used calcium gluconate during treatment.The patient tested positive for high calcium level.The operator overused the calcium infusion.The ae of hypertension is possibly related to the patient's underlying condition of uncontrolled blood pressure.There is probability that the fluid shift during treatment could have worsened this issue.Medical intervention of adalata was needed, therefore, this case is reportable as an mdr.(b)(4).

Event Description

Customer reported adverse event occurred during photoactivation in a blood prime procedure.During photoactivation, the patient started not feeling well: she was very warm and her blood pressure raised.The sensation lasted until photoactivation was completed.As soon as reinfusion started, the patient felt better.Anticoagulant used is acd-a with a ratio of 1:10.Throughout the whole treatment, there was a continous flow of calcium gluconate 10% at 18ml/hour.Prior to the treatment, css on-site advised to pause the calcium gluconate during photoactivation as there is no return during that phase.The responsible physician decided not to stop the calcium gluconate throughout the whole treatment.The case was updated with the following information obtained from the customer:.The events occurred about 10 minutes after photoactivation started.Was any treatment given? after the procedure, an antihypertensive ("adalata") was given to the child due to the high pressure.Calcium concentration in blood was detected to be 1.68 mmol/ml, when the upper limit is 1.35.The high calcium concentration in the blood was treated as well, after the procedure.There was no evidence of an allergic reaction.The patient had the following symptoms during the procedure: headache, redness of face, feeling very warm.During the treatment, the child became slightly positive in fluid balance.After the treatment: blood pressure: 150/104 mmhg, temperature: 36,7 degrees celsius.The initial blood pressure prior to the treatment was: 117/89 mmhg there was no increase in body temperature.The previous treatment was interrupted because of issues with the access.There were no late adverse events after the end of the ecp.One more ecp treatment was provided to the same patient 3 days later (on (b)(6)).The treatment was uneventful.In the opinion of the healthcare provider, the cause of the raised blood pressure and feeling warm was hypercalcemia.The healthcare provider does not think the event is related to the ecp.The patient has often alteration of blood pressure as a pathology regardless of extracorporeal photopheresis.The smart card was returned for investigation.

• 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: 5320987
• MDR Text Key: 34187384
• Report Number: 2523595-2015-00324
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2015

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: Nurse
• Device Expiration Date: 07/01/2017
• Device Lot Number: D134 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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: 14