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

Catalog Number 10316

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

Patient Problem Reaction (2414)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: study id: (b)(6) per the study outcome: (relationship to devices) probably related (relationship to wbcd procedure) probably related (measures taken for the studied devices): stop using investigation is in process.A follow-up report will be provided.

Event Description

An adverse event was reported related to a clinical study on white blood cell depletion (wbcd).Hypoalbuminemia was reported in the patient.The patient was given methylprednisolone sodium succinate needle and calcium gluconate injection.Patient outcome is unknown at this time.Patient age, weight, and sex are not available at this time.The disposable set is not available for return because it was discarded by the customer this product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.There were no signals to indicate the device contributed to the adverse patient reactions reported.A conclusive root cause for the adverse event related to hypoalbuminemia could not be determined from the dlog analysis.The system operated as intended.Investigation is in process.A follow up report will be provided.

Event Description

Patient gender and weight were obtained from the run data file.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10.Investigation: there were three waste bags, and each had cbc run twice: first time bag (wbc count) (rbc count) (hgb) (hct) (plt count) (*10e9/l) (*10e12/l) (g/l) (l/l) (*10e9/l) 1 47.30 0.02 1 0 2 2 61.14 0.05 3 0.007 5 3 56.49 0.05 3 0.008; 5 second time bag (wbc count) (rbc count) (hgb) (hct) (plt count) (*10e9/l) (*10e12/l) (g/l) (l/l) (*10e9/l) 1 47.94 0.02 1 0 5 2 57.82 0.05 4 0.007 4 3 57.82 0.04 4 0.007 6.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.Corrected information is provided in e.1 and e.3.Investigation: per internal medical review and analysis, the device did not cause or contribute to this incident.Root cause: a definitive root cause for the hypoalbuminemia could not be determined.Possible causes include are the patient's adverse pathological condition and/or the patient's sensitivity to the leukapheresis procedure.

Manufacturer Narrative

Investigation : a disposable history search of the lot number found no other reports of hypoalbuminemia.Per literature and medical review, hypoalbuminemia is a known side effect of the leukapheresis therapy.Hypoalbuminemia (among 30 other conditions) is listed as a previously reported patient reaction to apheresis procedures in the optia operator's manual on page 17.Operators are cautioned to be aware of the possible adverse events so that they may take appropriate action should they occur.Albumin, a major component of plasma protein, is required to maintain oncotic pressure, microvascular permeability, acid¿base function, and to prevent platelet aggregation.Serum albumin is an important parameter in the assessment of the nutritional status of both acute and chronically ill patients.The frequency of hypoalbuminemia, defined as serum albumin levels <3.5 g/dl, is 21% at the time of admission in adult hospitalized patients.De novo hypoalbuminemia and worsening of existing hypoalbuminemia are also common.Albumin levels may decrease owing to several factors: poor nutritional status; inflammation (eg, infectious disease, malignancy) due to interleukin-1 and tumor necrosis factor, which decrease production of albumin by the liver; renal disease or burns due to loss of albumin in the urine or the integument, respectively; trauma or surgery, as a result of the associated stress, which increases protein and energy requirements by creating hypermetabolic, catabolic state; and liver disease.The investigator with the customer site graded the hypoalbuminemia as a 2.Per ctcae, a grade 2 is "moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental adl" with values between <3 - 2 g/dl; <30 - 20 g/l.The subject¿s albumin value prior to the procedure is unknown and what replacement fluid was used for the wbcd.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Updated investigation: the run data file (rdf) was analyzed for this event.Review of the run data file associated with this procedure determined that no definitive root cause for the reported adverse event could be identified.Due to the nature of wbcd collections, some platelet loss and rbc loss is expected.The system operated as intended and the procedure was run within standard operating limits.The operator made no changes to the default packing factor and there were no excessive pump pauses during the run.No signs of aggregation were observed in the aim images; the collection preference (cp) was set to the default of 75 and the operator made several adjustments ranging from 65-78 throughout the procedure.The replacement fluid type was albumin/saline and the final fluid balance was 100%.Terumo bct does not recommend a replacement fluid type for wbcd procedures.Per the optia operator's manual, the appropriate replacement fluid type and replace volume to adequately support the patient is prescribed by the physician.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10779228
• MDR Text Key: 217138236
• Report Number: 1722028-2020-00493
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/03/2020

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 Expiration Date: 02/01/2021
• Device Catalogue Number: 10316
• Device Lot Number: 1902083130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/05/2020; 11/30/2020; 04/21/2021; 05/03/2021
• Supplement Dates FDA Received: 11/24/2020; 12/17/2020; 04/29/2021; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 72