MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA RBCX SET

Catalog Number	70600
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Anemia (1706); Fever (1858); Itching Sensation (1943); Rash (2033); Thrombocytopenia (4431); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Citation: matsui, h.M., hazama, s., nakajima, m., xu, m., matsukuma, s., tokumitsu, y., shindo, y., tomochika, s., yoshida, s., iida, m., suzuki, n., takeda, s., yoshino, s., ueno, t., oka, m., & nagano, h.(2020).Novel adjuvant dendritic cell therapy with transfection of heat-shock protein 70 messenger rna for patients with hepatocellular carcinoma: a phase i/ii prospective randomized controlled clinical trial.Cancer immunology, immunotherapy/cancer immunology and immunotherapy, 70(4), 945¿957.Https://doi.Org/10.1007/s00262-020-02737-y.
Event or Problem Description
Per journal article "novel adjuvant dendritic cell therapy with transfection of heat-shock protein 70 messenger rna for patients with hepatocellular carcinoma: a phase i/ii prospective randomized controlled clinical trial".By matsui, h.M., hazama, s., nakajima, m., xu, m., matsukuma, s., tokumitsu, y., shindo, y., tomochika, s., yoshida, s., iida, m., suzuki, n., takeda, s., yoshino, s., ueno, t., oka, m., nagano, h.Among the safety population cohort, aes were reported in 39 patients (88.6%); of these, 35 patients (79.5%) had mild to moderate aes (grade 1 or 2).The frequency of all aes between the two groups was comparable.Most of these aes were afected by background liver disease.In the dc group, two patients had grade 3 anemia and two patients had grade 3 thrombocytopenia.However, there was no signifcant change in liver function in these patients.Furthermore, although these patients met the inclusion criteria, anemia and thrombocytopenia were more prominent before dc treatment than in other cases.So, these aes were unlikely to be associated with dc therapy and likely to be related to liver cirrhosis or splenomegaly, which developed during the chronic course of the disease.The frequency of grade 3 aes between the two groups was also comparable.No patient in the dc group developed local skin reactions.Two patients of the dc group experienced transient fever, one patient of the dc group developed a grade 2 rash and one patient of the dc group developed grade 1 pruritus.These immune-related aes were well tolerated (table 2).We also evaluated aes associated with apheresis, but no aes of grade 2 or higher, including hypotension, bleeding, and air embolism were observed 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.It is unknown at this time if medical intervention was required for these events the collection set is not available for return because it was discarded by the customer.
Event or Problem Description
Per journal article "novel adjuvant dendritic cell therapy with transfection of heat-shock protein 70 messenger rna for patients with hepatocellular carcinoma: a phase i/ii prospective randomized controlled clinical trial".By matsui, h.M., hazama, s., nakajima, m., xu, m., matsukuma, s., tokumitsu, y., shindo, y., tomochika, s., yoshida, s., iida, m., suzuki, n., takeda, s., yoshino, s., ueno, t., oka, m., nagano, h.Among the safety population cohort, aes were reported in 39 patients (88.6%); of these, 35 patients (79.5%) had mild to moderate aes (grade 1 or 2).The frequency of all aes between the two groups was comparable.Most of these aes were afected by background liver disease.In the dc group, two patients had grade 3 anemia and two patients had grade 3 thrombocytopenia.However, there was no signifcant change in liver function in these patients.Furthermore, although these patients met the inclusion criteria, anemia and thrombocytopenia were more prominent before dc treatment than in other cases.So, these aes were unlikely to be associated with dc therapy and likely to be related to liver cirrhosis or splenomegaly, which developed during the chronic course of the disease.The frequency of grade 3 aes between the two groups was also comparable.No patient in the dc group developed local skin reactions.Two patients of the dc group experienced transient fever, one patient of the dc group developed a grade 2 rash and one patient of the dc group developed grade 1 pruritus.These immune-related aes were well tolerated (table 2).We also evaluated aes associated with apheresis, but no aes of grade 2 or higher, including hypotension, bleeding, and air embolism were observed 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.It is unknown at this time if medical intervention was required for these events the collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Corrected information is provided in d.4.Lot number, manufacture and expiry date are not available at this time.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that there were no aes associated with apheresis that were greater than grade 2 or higher.No further reporting will be provided as this does not represent a reportable event.¿¿ citation: matsui, h.M., hazama, s., nakajima, m., xu, m., matsukuma, s., tokumitsu, y., shindo, y., tomochika, s., yoshida, s., iida, m., suzuki, n., takeda, s., yoshino, s., ueno, t., oka, m., & nagano, h.(2020).Novel adjuvant dendritic cell therapy with transfection of heat-shock protein 70 messenger rna for patients with hepatocellular carcinoma: a phase i/ii prospective randomized controlled clinical trial.Cancer immunology, immunotherapy/cancer immunology and immunotherapy, 70(4), 945¿¿¿957.Https://doi.Org/10.1007/s00262-020-02737-y.

• Brand Name: COBE SPECTRA
• Common Device Name: COBE SPECTRA RBCX 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: 19606505
• Report Number: 1722028-2024-00274
• Device Sequence Number: 15042687
• Product Code: GKT
• UDI-Device Identifier: 05020583706002
• UDI-Public: 05020583706002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK080035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 70600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown