MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Model Number 10220

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

Patient Problems Bacterial Infection (1735); Sepsis (2067)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: tsitsikas, d.A., badle, s., hall, r., meenan, j., bello-sanyaolu, o., orebayo, f., abukar, j., elmi, m., mulla, a., dave, s., lewis, n., sharma, m., chatterjee, b., amos, r.J.Automated red cell exchange in the management of sickle cell disease.Journal of clinical medicine.2021.10:1 investigation is in process.A follow up report will be provided.

Event Description

In the article, "automated red cell exchange in the management of sickle cell disease", the authors describe their experience of automated red cell exchange (a-rce) for management of sickle cell disease since 2011.A transient reduction in the platelet count by 61% was observed after the procedure.This was not associated with any hemorrhagic complications.Despite exposure to large volumes of blood, the alloimmunization rate was only 0.027/100 units of red cells.The absence of any iron loading was confirmed by serial ferriscans, performed over a number of years.Patients with advanced chronic kidney disease showed evidence of iron loading due to reduced innate hemopoiesis and were subsequently switched to simple transfusions.A total of 59% of patients were on regular automated red cell exchange with a history of recurrent painful crises.A total of 77% responded clinically, as evidenced by at least a 25% reduction in their emergency hospital attendance for pain management.The clinical response was gradual and increased the longer patients stayed on the program.The earliest sign of clinical response was a reduction in the length of stay when these patients were hospitalized, indicating that a reduction in the severity of crises precedes the reduction in their frequency.Automated red cell exchange also appeared to be beneficial for patients with recurrent leg ulcers and severe, drug resistant stuttering priapism, while patients with pulmonary hypertension showed a dramatic improvement in their symptoms as well as echocardiographic parameters.Adverse events: ¿ line-related: one episode of sepsis (e.Coli) specific details regarding what, if any, medical intervention was required for the adverse event were not included in the article.The article did not provide specific patient information, therefore this report is being filed as a summary of the event.The disposable sets are not available for return from the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: according to the article, "the spectra optia apheresis system (terumo bct) was used by nurses trained and signed as being competent at performing the procedure.Red cell units meeting specifications as per national guidelines for patients with scd [5] were provided by the national blood service.All elective procedures were performed as day cases (ambulatory a-rce) in our day unit with same day discharge for the vast majority of patients.Even though when we first started, intravenous access was via temporary femoral central catheters (vas-cath) for the majority of patients, progressively, an increasing number have the procedure using peripheral access.Currently, 48 of the 68 patients (71%) have the procedure performed through peripheral cannulas, 18 g, 20 g or 22 g according to body habitus, while an additional 15 (22%) through peripheral deep access lines 18 or 20 g, inserted under ultrasound guidance by trained by trained nurses in our day unit.The infusion rate of the citrate anticoagulant is set at 0.6 ml/min when patients first enter the programme and then, if tolerated, increased to 0.8 ml/min." according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Adverse effects related to vascular access are a frequent concern.Hematoma, venous sclerosis and thrombosis can complicate percutaneous needle puncture.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.During a dressing change, the site should be cleaned and observed for signs of infection such as redness, swelling, drainage, and foul odor.If an infection is suspected, cvc removal should be considered, and the patient should be treated for infection as appropriate.Per internal sterility lab documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11608130
• MDR Text Key: 243731156
• Report Number: 1722028-2021-00140
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

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: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other