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

Catalog Number 10300

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

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 03/18/2013

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

The customer reported that a patient was undergoing a white blood cell depletion (wbcd)procedure.Approximately 2 hours post procedure, the patient developed rapid pulse, hypotension, anaemia, low blood pressure, and the patient's platelet count decreased.The operator consulted with a physician.Per physician's order, fluid medications were administered to the patient.The customer stated that the patient's symptoms of low blood pressure and rapid pulse were resolved and the patient recovered.Patient's age is not available at this time.Patient's gender and weight were obtained from the run data file (rdf).The wbcd collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A physician evaluated the adverse event for causality.The physician determined that the device did not contribute to the adverse events.The adverse reaction was possibly related to the procedure, and unrelated to the treatment of the patient's disease.The platelet count decrease and anemia were determined to be definitely related to the patient's disease state.The rapid pulse was determined to be probably related to the patient's disease state.The low blood pressure was determined to be unrelated to the patient's disease state.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 hypocalcaemia 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.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%.This could have contributed to the loss of platelets and red blood cells during the procedure, and the patient's decrease in platelet count and anemia observed 2 hours post procedure.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic leukocytapheresis with a frequency of 5.7%.Root cause: based on the risk assessment, clinical findings, and investigation, the root cause of the patient reaction and need for medical intervention is inconclusive.Possible causes include but are not limited to the patient's disease state, and/or the nature of the wbcd procedure citation:hölig, kristina, and rainer moog."leukocyte depletion by therapeutic leukocytapheresis inpatients with leukemia." transfusion medicine and hemotherapy 39.4 (2012): 241-245.

Event Description

Due to eu personal data protection laws, the patient's age is not available from the customer.

• 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: 6663649
• MDR Text Key: 78290034
• Report Number: 1722028-2017-00258
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: BK120012
• 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
• Report Date: 06/23/2017

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: 09/01/2014
• Device Catalogue Number: 10300
• Device Lot Number: 09U3217
• Other Device ID Number: 05020583103009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 08/11/2017
• Supplement Dates FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2012
• 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: 80