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

Catalog Number 10300

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Reaction (2414)

Event Date 06/13/2012

Event Type  Injury  

Manufacturer Narrative

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 experienced anemia.Per physician's order, the patient was given a red blood cell (rbc) transfusion.The customer stated that the patient's anemia was resolved and the patient recovered.Patient's age, gender and weight are not available at this time.The wbcd collection set is not available for return because it was discarded by the customer.

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 (b)(6) 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 and corrected information in.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%.A physician with the clinical trial evaluated the adverse event for causality.The physician determined that the adverse event was related to the treatment of the patients underlying disease.Additionally, it was determined that the spectra optia device did not contribute to the adverse events.Based on the physician's assessment, the anemia and hypogammaglobulinaemia were definitely related to the patient¿s disease state while the hypoproteinaemia was possibly related to the patient disease state.The physician also noted that the event was either possibly or probably related to the patient undergoing the apheresis procedure.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 therapeuticle ukocytapheresis procedure.Examples of contraindications from wbcd procedures listed from the article include anemia.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.Root cause: based on the physician review, the root cause for the anemia and hypogammaglobulinaemia was due to patient disease state.Based on risk assessment, literature review, clinical findings, physician review, and log analysis, the root cause for the hypocalcemia and hypoproteinaemia was inconclusive.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 therapeuticle ukocytapheresis in patients with leukemia.Transfusion medicine and hemotherapy, 39(4),241-245.Doi:10.1159/000341805.

• 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: 6609273
• MDR Text Key: 76592679
• Report Number: 1722028-2017-00212
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K103090
• 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
• Report Date: 06/02/2017

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: 09/01/2013
• Device Catalogue Number: 10300
• Device Lot Number: 09T3119
• Other Device ID Number: 05020583103009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: Not provided; 07/12/2017
• Supplement Dates FDA Received: 06/27/2017; 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2011
• 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: 75