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

Catalog Number 10220

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: tsitsikas, da, et al.2016.Safety, tolerability, and outcomes of regular automated red cell exchange transfusion in the management of sickle cell disease.Journal of clinical apheresis.2016; 31:545¿550.Investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.

Event Description

The article, 'safety, tolerability, and outcomes of regular automated red cell exchange transfusion in the management of sickle cell disease' (tsitsikas 2016) describes 50 patients who underwent 504 regular automated red blood cell exchange (rbcx) procedures with spectra optia.Twenty-seven patients were male and 23 female with a mean age of 38 (19¿58).During the study, the mean pre-transfusion platelet (plt) count was 352 x 10^9/l (65¿765) and the mean post-transfusion plt count was 106 x 10^9/l (19¿593) representing a 70% reduction.Of note, the post- transfusion plt count was <100 x 10^9/l and <50 x 109/l (described as severe thrombocytopenia) on 49% (247 procedures) and 6% of procedures (30 procedures), respectively.Three of the 50 (6%) patients developed a total of four new antibodies while on regular automated rbcx procedures representing a rate of formation of new antibodies of 0.065/100 units of red cells.Microbial contamination was reported in 14 of the cases: ¿ line-related e.Coli sepsis: 1 patient (2%) ¿ culture positive line tips: 5% (13/238) positive, including 8 positive tips from patient who developed line-related e.Coli sepsis.Other isolated bacteria included 10 coagulase negative staphylococcus, one micrococcus luteus, one acinetobacter iwoffii, and one e.Coli.Other than the e.Coli, none of the other positive line tip cultures were associated with clinical infection.Specific details, such as patient information, outcome or if medical intervention were required for these events were not included in the article for these events, therefore this report is being provided as a summary of the events.The disposable set is not available for return because it was discarded by the customer.

Event Description

Twenty-seven patients were male and 23 female with a mean age of 38 (range 19¿58).This was a retrospective study between (b)(6) 2011 and (b)(6) 2014 to assess the efficacy of regular automated red cell exchange transfusion in the management of sickle cell disease.A request for specific patient information is not feasible.

Manufacturer Narrative

This report is being filed to provide additional information in b5 and h10.Investigation: dhr details: since this was a retrospective study between (b)(6) 2011 and (b)(6) 2014, the lot numbers are unknown; therefore, dhr searches could not be conducted for the reported incidents.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10.Investigation: per internal sterility 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: 10422287
• MDR Text Key: 231727131
• Report Number: 1722028-2020-00397
• Device Sequence Number: 1
• Product Code: LKN
• 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,Followup
• Report Date: 08/18/2020

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 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: 02/01/2019
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 05/12/2022; 06/21/2022
• Supplement Dates FDA Received: 05/27/2022; 06/22/2022
• 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