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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Electrolyte Imbalance (2196)

Event Date 09/13/2022

Event Type  Injury  

Event Description

The journal article, peripheral blood stem cells collection by apheresis in very low-weight children with malignant diseases-a single center experience, describes a retrospective study on pediatric peripheral blood stem cell (pbsc) collection in patients weighing under 10kg, between 2006-2021.Until 2012, cobe spectra apheresis system (version 6.1, terumobct, lakewood, colorado) was used.Since then, spectra optia (version 11.3, terumobct) was used.Sixteen apheresis procedures, performed in 13 patients with up to 10 kg of body weight, were analyzed.The study described the following adverse events (aes) - pre-apheresis anemia was present in all procedures and worsened in seven of them (it progressed from grades 1 to 2 in five of the sessions and from grades 2 to 3 in two others).Pre-procedure grade 1 thrombocytopenia was present in one case, and progressed to grade 2 after the collection.Of the remainder, all with baseline normal platelet counts, eight progressed to grade 1 thrombocytopenia.Apheresis-related hypokalemia occurred in one case.Supplementation with intravenous magnesium sulfate was required in one patient with hypomagnesemia and unspecified irritability; paracetamol was also intravenously administered, thinking in a potential pain/discomfort.Mild tremor was presented by one patient, requiring an additional administration of calcium gluconate.Cvc issues.In two leukocytapheresis sessions, both performed in spectra optia and using only acd-a as anticoagulant, the second chamber was not concluded/cleared.In one of them, an excessive pressure warning was observed, resulting in the removal of a fibrin filament, measuring approximately 15 cm, from the lumen of the cvc used for the extraction.Two additional clots were observed in the container.Specific patient details are not provided in the article, therefore, this report is being filed as a summary of events.Neuroblastoma was the most frequent diagnosis.The mean age, at the time of the procedure, was 13.31 months and the mean weight was 8.31 kg).There were nine female patients (69%) and four male patients.The exchange sets are not available for return for evaluation.

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: vieira, l.,teixeira, s.,reis, c.,salselas, a.,bordalo, f.,lopes, s.,pinho, c.,amado, f.,roncon, s.Peripheral blood stem cells collection by apheresis in very low-weight children with malignant diseases-a single center experience.J clin apher.2022.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 15788203
• MDR Text Key: 303552866
• Report Number: 1722028-2022-00362
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2022

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 Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/14/2022
• 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