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

Model Number 10310

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

Patient Problems Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the article "hpc-a was performed after the 3rd cycle of chemotherapy.Gcsf (10mcg/kg/day x 13 days) and plerixafor (0.24mg/kg/dose x 1 dose iv on the night prior to hpc-a) were used for stem cell mobilization.Peripheral blood cd 34 count on day of collection was 290.9/ul.Patient's weight on day of procedure was 4.75 kg.A double lumen apheresis catheter (7.5 fr) was used for vascular access, placed by interventional radiology in the left internal jugular vein.The spectra optia (terumo bct, lakewood, colorado) continuous mononuclear cell (cmnc) protocol was used, and the circuit was primed with packed red blood cells prior to the apheresis procedure.Anticoagulant citrate dextrose (acd-a) was used for anticoagulation; inlet flow rate was maintained at 10 ml/min.Patient received calcium gluconate during the procedure as a continuous infusion.Ionized calcium at the start of procedure was 1.38 mm/l, mid procedure ionized calcium level was 1.09 mm/l, calcium gluconate infusion rate was increased in response to the mid procedure level.Total number of cd34 cells collected was 32.6 million/kg (goal for collection-15 million/kg).Total blood processed - 1200 ml, total product volume collected - 56ml and total blood volume of patient- 376ml.The goal for collection was achieved with a single procedure which was completed in 135 minutes in the pediatric intensive care unit." citation: cacacchia, c., salcedo, t.S., & puthenveetil, g.(2023).Successful hematopoietic progenitor cell collection via apheresis hpc-a in a very low weight infant with atypical teratoid/rhabdoid tumor using granulocyte colony stimulating factor and plerixafor [paper presentation].American society for apheresis 44th annual meeting.Investigation is in process, a follow-up report will be provided.

Event Description

In the journal article " successful hematopoietic progenitor cell collection via apheresis hpc-a in a very low weight infant with atypical teratoid/rhabdoid tumor using granulocyte colony stimulating factor and plerixafor" it was reported that a patient had some tachycardia towards the end of the procedure which resolved with intravenous hydration.The reported procedure was a successful hpc-a collection on a 4.75 kg infant with atypical teratoid/rhabdoid tumor (atrt) using granulocyte colony stimulating factor (gcsf) and plerixafor for hpc mobilization.Patient tolerated the procedure without any significant adverse effects such as hypotension, bradycardia, or bleeding symptoms.Further details of the patient and procedure were not included in the article for this event.The collection set is not available for return because it was discarded by the customer.

Event Description

In the journal article " successful hematopoietic progenitor cell collection via apheresis hpc-a in a very low weight infant with atypical teratoid/rhabdoid tumor using granulocyte colony stimulating factor and plerixafor" it was reported that a patient had some tachycardia towards the end of the procedure which resolved with intravenous hydration.The reported procedure was a successful hpc-a collection on a 4.75 kg infant with atypical teratoid/rhabdoid tumor (atrt) using granulocyte colony stimulating factor (gcsf) and plerixafor for hpc mobilization.Patient tolerated the procedure without any significant adverse effects such as hypotension, bradycardia, or bleeding symptoms.Further details of the patient and procedure were not included in the article for this event.The collection 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 e.1, h.6 and h.10.Investigation: per the article "hpc-a was performed after the 3rd cycle of chemotherapy.Gcsf (10mcg/kg/day x 13 days) and plerixafor (0.24mg/kg/dose x 1 dose iv on the night prior to hpc-a) were used for stem cell mobilization.Peripheral blood cd 34 count on day of collection was 290.9/ul.Patient's weight on day of procedure was 4.75 kg.A double lumen apheresis catheter (7.5 fr) was used for vascular access, placed by interventional radiology in the left internal jugular vein.The spectra optia (terumo bct, lakewood, colorado) continuous mononuclear cell (cmnc) protocol was used, and the circuit was primed with packed red blood cells prior to the apheresis procedure.Anticoagulant citrate dextrose (acd-a) was used for anticoagulation; inlet flow rate was maintained at 10 ml/min.Patient received calcium gluconate during the procedure as a continuous infusion.Ionized calcium at the start of procedure was 1.38 mm/l, mid procedure ionized calcium level was 1.09 mm/l, calcium gluconate infusion rate was increased in response to the mid procedure level.Total number of cd34 cells collected was 32.6 million/kg (goal for collection-15 million/kg).Total blood processed - 1200 ml, total product volume collected - 56ml and total blood volume of patient- 376ml.The goal for collection was achieved with a single procedure which was completed in 135 minutes in the pediatric intensive care unit." citation: cacacchia, c., salcedo, t.S., & puthenveetil, g.(2023).Successful hematopoietic progenitor cell collection via apheresis hpc-a in a very low weight infant with atypical teratoid/rhabdoid tumor using granulocyte colony stimulating factor and plerixafor [paper presentation].American society for apheresis 44th annual meeting.Since this was a journal publication presenting data of a retrospective chart review to gather the data for a case report involving a pediatric patient who underwent hpc-a on the spectra optia, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Since this was a journal publication presenting data of a retrospective chart review to gather the data for a case report involving a pediatric patient who underwent hpc-a on the spectra optia, the lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: a root cause assessment was performed for the adverse reactions.The reported adverse reactions are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.

• 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: 17112492
• MDR Text Key: 317766942
• Report Number: 1722028-2023-00209
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• 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): Required Intervention; Other
• Patient Weight: 5 KG