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

Catalog Number 10300

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/26/2012

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf confirmed that the spectra optia device operated as intended and no system or device malfunction was identified that may have contributed to the reported event.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient's age is not available from the customer patient's gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf confirmed that the spectra optia device operated as intended and no system or device malfunction was identified that may have contributed to the reported event.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient's age is not available from the customer patient's gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic leukocytapheresis with a frequency of 5.7%.According to the article 'leukocyte depletion by therapeutic leukocytapheresis in patients with leukemia', wbcd procedures are used to symptomatically treat patients with high wbc counts that are the result of an underlying diseases, such as leukemia.The diagnosis for the patient in this record is unknown.However, the article serves as a reference for adverse events that can occur and should be monitored for during a therapeutic leukocytapheresis procedure.Examples of contraindications from wbcd procedures listed from the article include anemia and thrombocytopenia.Additionally, the article states that patients should be asked about parasthesia due to hypocalcemia and recommends they receive calcium supplements.Also, calcium and potassium levels should be monitored and corrected by intravenous infusion, if necessary.Finally, the article recommends continuous measurement of heart rate and blood pressure monitoring in these patients undergoing leukocytapheresis procedures.Root cause: based on the risk assessment, literature review, clinical findings, physician review, and dlog analysis, the root cause for the adverse reactions of temporary hypotension, hypoalbuminaemia, hypokalemia, and thrombocytopenia are undetermined.Possible causes include but are not limited to the patient's disease state and/or the nature of wbcd procedures.Citation: hölig, k., & moog, r.(2012).Leukocyte depletion by therapeutic leukocytapheresis in patients with leukemia.Transfusion medicine and hemotherapy, 39(4), 241-245.Doi:10.1159/000341805.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Additional investigation: a physician evaluated the adverse event for causality.The physician determined that the adverse event were related to the treatment of the patients underlying disease.Additionally, it was determined that the device did not contribute to the adverse event.Based on the physicians assessment, the adverse event was either probably or possibly related to the apheresis procedure and the patients underlying disease.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Updated investigation: according to the article 'leukocyte depletion by therapeutic leukocytapheresis in patients with leukemia', wbcd procedures are used to symptomatically treat patients with high wbc counts that are the result of an underlying diseases, such as leukemia.These patients are not healthy individuals and often may be in crisis mode prior to the procedure.Patients undergoing this treatment may have pre-existing blood conditions such as thrombocytopenia (low platelet counts) and/or anemia (low hematocrit (hct) /hemoglobin).Moreover, the elevated wbc counts in these patients leads to an increase in blood viscosity, which in turn causes poor separation of the blood during the centrifugation process during the apheresis procedure.This can result in the collection of plasma, platelets, and rbcs with the wbc during the procedure.Under optimal condition, the hematocrit of the collected product can range from 3-5%.Per the article, albumin is one of the proteins that is found within plasma, and the loss of plasma during the procedure can result in hypoalbuminaemia.Additionally, clotting factors are found in the plasma, and loss of these factors can lead to the inability to form clots, which can result in coagulopathy.The loss of platelets and rbcs can result in thrombocytopenia and anemia, respectively.Per the handbook for therapeutic apheresis, a possible outcome with depletion procedures is a reduction in the patient total blood volume due to the intended removal of wbcs.This has the potential to result in hypotension which occurs at a frequency of 1%.The run data file (rdf) was analyzed for this event.Signals in the rdf confirmed that the spectra optia device operated as intended and no system or device malfunction was identified that may have contributed to the reported event.Analysis of the rdf determined that these types of procedures typically run at a high ac infusion rate.The acda binds to the free calcium in the blood to prevent the clotting cascade from occurring.Once calcium is no longer available, the acda will bond to other ions such as potassium.This can result in hypokalaemia (low potassium) post procedure.Per clinical guide to transfusion, hypomagnesaemia (like hypocalcemia) is a type of electrolyte imbalance that can occur during therapeutic apheresis procedures.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6608211
• MDR Text Key: 76534478
• Report Number: 1722028-2017-00205
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: 10300
• Device Lot Number: 01U3117
• Other Device ID Number: 05020583103009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2012
• 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 Weight: 59