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

Model Number 10220

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Insufficient Information (4580)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: macabeo et al.2021.Performance validation of tpe on spectra optia system journal of clinical apheresis.2021; 37:266-267.Investigation is in process.A follow-up report will be provided.

Event Description

The conference abstract "performance validation of tpe on spectra optia system" by macabeo et al presented a validation approach of spectra optia for therapeutic plasma exchange (tpe) after the center switched from the cobe spectra system to spectra optia.Twenty-five procedures were analyzed, some of which were collected retrospectively.One patient developed a mild rash, and there were no major adverse reactions.The authors conclude that "tpe on the spectra optia is effective, relatively safe and well-tolerated by patients." the article reported that a patient developed a mild rash to ffp that resolved quickly with intravenous diphenhydramine.Specific details, such as patient information and outcome, 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.

Manufacturer Narrative

Investigation: in collaboration with our quality program, five parameters were identified for this validation to establish the efficacy and safety of tpe on the spectra optia ¿ pre- and post-procedure fibrinogen, platelet (plt) count, hematocrit (hct), absolute neutrophil count (anc) and notation of any major adverse reactions to tpe.A determination was made from prior experience with the cobe spectra and from literature review that at least 40%-45% reduction in fibrinogen is anticipated in tpes using 5% albumin only as a replacement fluid, suggesting removal of plasma proteins.A larger tolerance of up to 35% plt loss was allowed, reflecting our experience with ttp and baseline moderate to severe thrombocytopenia with greater variability in pre and post-tpe counts.Up to 5% hct drop was thought to be reasonable.Because anc was not consistently evaluated, a drop in anc of up to 15% was added as an ancillary outcome parameter and was not required for final validation.Data analyzed were from tpe procedures on the spectra optia from 2019 to 2020.As part of the data was collected retrospectively, procedures with incomplete data were excluded from the laboratory evaluation.A sample size of 25 procedures was deemed adequate.All tpes performed however within the specified time period were reviewed for any major adverse events.Md orders were received for post-tpe laboratory testing for tpes validated prospectively.Results: data show that changes in the pre- and post procedure lab parameters are within the acceptance criteria.Change in hct is within +5% of pre-procedure values.A +4% change in hct on 1 patient was attributed to a blood transfusion received right before tpe.There was an average of 65% fibrinogen loss (1-1.4 total plasma volume exchange) and consistently >45% depletion of fibrinogen which signifies effective removal of patient plasma.5 of the 14 tpes had minimal decrease of <15% in anc while the rest had a rise.4 tpes on a ttp patient led to plt count rise, the rest had <35% plt drop.No major adverse reactions were noted.1 patient developed a mild rash to ffp that resolved quickly with intravenous diphenhydramine.Conclusion: all procedures in the study passed the acceptance criteria we designed for our performance validation.Data show that tpe on the spectra optia is effective, relatively safe and well-tolerated by patients.There was consistent post-procedural depletion of fibrinogen but no bleeding event was seen.With frequent tpe procedures, fibrinogen level should be monitored and may require repletion to avoid bleeding complications.Since this is a study which investigated twenty-five procedures from 2019 to 2020, some of which were collected retrospectively, the lot number was not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Article citation: macabeo et al.2021.Performance validation of tpe on spectra optia system journal of clinical apheresis.2021; 37:266-267.According to the aabb circular of information for the use of human blood components (revised 2017), allergic reactions frequently occur (ie, 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually respond to antihistamines.More severe manifestations, including respiratory and cardiovascular symptoms, are more consistent with anaphylactoid/anaphylactic reactions and may require more aggressive therapy.No laboratory procedures are available to predict these reactions.Root cause: a root cause assessment was performed for the patient who develop a rash.The authors attributed to the reaction to the fresh frozen plasma.

Event Description

The conference abstract "performance validation of tpe on spectra optia system" by macabeo et al presented a validation approach of spectra optia for therapeutic plasma exchange (tpe) after the center switched from the cobe spectra system to spectra optia.Twenty-five procedures were analyzed, some of which were collected retrospectively.One patient developed a mild rash, and there were no major adverse reactions.The authors conclude that "tpe on the spectra optia is effective, relatively safe and well-tolerated by patients." the article reported that a patient developed a mild rash to ffp that resolved quickly with intravenous diphenhydramine.Specific details, such as patient information and outcome, 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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 12051258
• MDR Text Key: 261922013
• Report Number: 1722028-2021-00223
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 01/16/2023
• 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): Required Intervention; Other