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

Model Number 12320

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

Patient Problem Numbness (2415)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the procedure on a patient with multiple myeloma, the patient reported "his hands fell asleep".The nurse administered calcium gluconate, but the patient continued to feel numbness in his hands, and after finishing the process the patient was evaluated by the hematology service and referred to the emergency room.Six hours after that, the patient discharged from the hospital.Per the customer the patient is stable.Patient identifier is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10, updated information in b.5 to reflect the gender update and corrected information in a.3.Investigation : the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.All acda lots must meet acceptance criteria for release.A disposable complaint history search for this lot number found one other report of a similar failure reported on mdr 1722028-2021-00166.According to anticoagulation techniques in apheresis: from heparin to citrate and beyond, citrate related complications have been reported to occur in: 1.2% of donors during voluntary donation, 7.8% of patients undergoing therapeutic plasma exchange procedures, and 48% of patients undergoing large volume leukapheresis during peripheral blood progenitor cell collection.Symptoms of hypocalcemia and other citrate-induced metabolic abnormalities affect neuromuscular and cardiac function and range in severity from mild dysesthesias (most common) to tetany, seizures, and cardiac arrhythmias.The run data file was analyzed for this event.Review of the run data file and run summary data indicates there were no abnormal issues during the procedure and the ac infusion rate was set to 0.80 ml/min/ltbv which is within the recommended limit.A routine citrate infusion rate of 1-1.8 mg/kg/min is known to result in a 25-35% reduction in ionized calcium levels.Hypocalcemia is defined as an ica2+ of <4.5 mg/dl (1.1 mmol/l).Symptoms manifest variably when ica2+ levels fall below normal range.Factors influencing hypocalcemia symptom development include rate of citrate infusion, the rate of decline in ionized calcium levels, and hepatic metabolism of the infused citrate.There is considerable individual variability in the development of symptoms and signs of citrate-induced hypocalcemia.Predictors of citrate toxicity include older age, female gender, lower body weight, and blood volume less than 4 liters.Patients with comorbid conditions such as hepatic or renal insufficiency may be at increased risk of citrate toxicity due to impaired metabolism of citrate.A low baseline serum albumin also places patients at risk for developing citrate-related symptoms, as albumin-bound calcium normally disassociates to counter-act decreases in ionized calcium levels.Presence of these risk factors and/or comorbidities may identify patients who will benefit from procedural modifications or calcium supplementation.Technical issues may also predispose a patient to developing citrate toxicity.Longer procedures will result in citrate accumulation.Large volume procedures will inevitably result in a larger volume of infused citrate.The final citrate load to the patient is also considerably higher when ffp is used as replacement fluid, as it contains approximately 15% citrate by volume.Not surprisingly, the risk of citrate toxicity and hypocalcemia will also be higher when apheresis is performed on consecutive days.[g.Lee, g.M.Arepally.Anticoagulation techniques in apheresis: from heparin to citrate and beyond.J clin apher.2012 ; 27(3): 117¿125.] root cause : a definitive root cause for the hypocalcemia reaction could not be determined.Possible causes include but are not limited to: - the patient's sensitivity to the anticoagulation infusion rate due to physiology and/or underlying disease state - the duration of the procedure - the volume of blood processed.

Event Description

The customer reported that during the procedure on a patient with multiple myeloma, the patient reported "her hands fell asleep".The nurse administered calcium gluconate, but the patient continued to feel numbness in her hands, and after finishing the process the patient was evaluated by the hematology service and referred to the emergency room.Six hours after that, the patient discharged from the hospital.Per the customer the patient is stable.

Manufacturer Narrative

This report is being filed to provide corrected information in h10.Corrected investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the hypocalcemic reaction.All quality labs and sterilization requirements passed.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11760672
• MDR Text Key: 248517178
• Report Number: 1722028-2021-00165
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2010223130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACD LOT: 20063035; ACD LOT: 20063035
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00046 YR
• Patient Weight: 43