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

Catalog Number 12320

Device Problem Insufficient Information (3190)

Patient Problems Convulsion/Seizure (4406); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.Citation: bray k, lynde c, vu t, et al.Prevalence of baseline hypocalcemia and symptomatic hypocalcemia during leukapheresis.J clin apher.2023;1-10.Doi:10.1002/jca.22076.

Event Description

Per journal article "prevalence of baseline hypocalcemia and symptomatic hypocalcemia during leukapheresis" by bray et al.Symptoms of hypocalcemia are reported in up to 50% of patients undergoing leukapheresis procedures.There is no set standard of practice for administering calcium supplementation in the prevention or treatment of hypocalcemia symptoms.The goal of this descriptive, retrospective study was to determine the prevalence of baseline hypocalcemia and symptomatic hypocalcemia during leukapheresis with acid citrate dextrose solution a and to identify patient characteristics associated with symptomatic hypocalcemia.Three percent of patients were found to have hypocalcemia before leukapheresis with 35% experiencing hypocalcemia symptoms during leukapheresis.Older age, higher albumin levels, and longer procedure time were associated with increased risk of hypocalcemia symptoms medical intervention in the form of prophylactic calcium supplementation administered the collection set is not available for return because it was discarded by the customer.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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• 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
• MDR Report Key: 17768883
• MDR Text Key: 323656864
• Report Number: 1722028-2023-00307
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Other