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

Catalog Number	70500
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemolysis (1886); Local Reaction (2035); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2001
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the journal article, "adverse reactions associated with mobile therapeutic apheresis:analysis of 17,940 procedures." by dobri d.Kiprov, patricia golden, regina rohe, sheila smith, jan hofmann,and john hunnicutt."only 2 of 3,583 patients (0.06%) had a fatal event during or shortly after receiving therapeutic plasmapheresis.Neither of these deaths were attributed to the use of plasmapheresis." "adverse reactions were observed in 3.9% (700) of all procedures.The following adverse reactions were documented: reactions related to acd toxicity (3%), vasovagal reactions (0.5%), vascular access related complications (0.15%), reactions related to ffp (0.12%), hepatitis b from ffp (0.06%), arrhythmias (0.01%), hemolysis due to inappropriate dilution of 25% albumin (0.01%), and one death (from underlying disease) during a ta procedure (0.006%) (table ii).The majority of adverse reactions were mild or moderate (table iii).The most common reactions related to vascular access were seen in patients with central venous catheters (table iv).The most frequent side effect was acd toxicity.Acd toxicity was four times as frequent in patients with myasthenia gravis than in patients with other diseases (fig.1).Prolonged procedures due to inadequate vascular access, equipment malfunction, or empty stomach were associated with an increased rate of acd toxicity and vasovagal reactions.Patients receiving ffp or cpp had significantly higher rates of adverse reactions (fig.2) than patients receiving other exchange fluids.The most common reactions experienced by patients receiving plasma are shown in table v.These reactions occurred despite premedication with hydrocortisone and diphenhydramine hydrochloride.Additional medical intervention was required in almost all patients who developed plasma related reactions.Two patients (0.06%) developed hepatitis b infection after extensive courses of plasmapheresis with ffp for ttp.Since both patients received other blood products besides ffp during the same period of time, it is impossible to determine which blood product was contaminated.While adverse reactions to other exchange fluids were rare, three patients (0.08%) experienced moderate allergic reactions to 5% albumin on more than one occasion" this article contains information concerning a patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.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.It is unknown that this time if medical intervention was required for these events.
Additional Manufacturer Narrative
Citation: kiprov, d.D., golden, p., rohe, r., smith, s., hofmann, j., & hunnicutt, j.(2001).Adverse reactions associated with mobile therapeutic apheresis: analysis of 17,940 procedures.Journal of clinical apheresis, 16(3), 130-133.Https://doi.Org/10.1002/jca.1024 investigation is in process.A follow-up report will be provided.
Event or Problem Description
Per the journal article, "adverse reactions associated with mobile therapeutic apheresis: analysis of 17,940 procedures." by dobri d.Kiprov, patricia golden, regina rohe, sheila smith, jan hofmann, and john hunnicutt."only 2 of 3,583 patients (0.06%) had a fatal event during or shortly after receiving therapeutic plasmapheresis.Neither of these deaths were attributed to the use of plasmapheresis." "adverse reactions were observed in 3.9% (700) of all procedures.The following adverse reactions were documented: reactions related to acd toxicity (3%), vasovagal reactions (0.5%), vascular access related complications (0.15%), reactions related to ffp (0.12%), hepatitis b from ffp (0.06%), arrhythmias (0.01%), hemolysis due to inappropriate dilution of 25% albumin (0.01%), and one death (from underlying disease) during a ta procedure (0.006%) (table ii).The majority of adverse reactions were mild or moderate (table iii).The most common reactions related to vascular access were seen in patients with central venous catheters (table iv).The most frequent side effect was acd toxicity.Acd toxicity was four times as frequent in patients with myasthenia gravis than in patients with other diseases (fig.1).Prolonged procedures due to inadequate vascular access, equipment malfunction, or empty stomach were associated with an increased rate of acd toxicity and vasovagal reactions.Patients receiving ffp or cpp had significantly higher rates of adverse reactions (fig.2) than patients receiving other exchange fluids.The most common reactions experienced by patients receiving plasma are shown in table v.These reactions occurred despite premedication with hydrocortisone and diphenhydramine hydrochloride.Additional medical intervention was required in almost all patients who developed plasma related reactions.Two patients (0.06%) developed hepatitis b infection after extensive courses of plasmapheresis with ffp for ttp.Since both patients received other blood products besides ffp during the same period of time, it is impossible to determine which blood product was contaminated.While adverse reactions to other exchange fluids were rare, three patients (0.08%) experienced moderate allergic reactions to 5% albumin on more than one occasion" this article contains information concerning a patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.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.It is unknown that this time if medical intervention was required for these events.
Additional Manufacturer Narrative
Investigation: 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 are 2 medical devices used in the article, however, there is no allegation the adverse reactions were related to a tbct device.No further reporting will be provided as this does not represent a reportable event.Citation: kiprov, d.D., golden, p., rohe, r., smith, s., hofmann, j., & hunnicutt, j.(2001).Adverse reactions associated with mobile therapeutic apheresis: analysis of 17,940 procedures.Journal of clinical apheresis, 16(3), 130-133.Https://doi.Org/10.1002/jca.1024.

• Brand Name: COBE SPECTRA
• Common Device Name: COBE SPECTRA TPE 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: 22879540
• Report Number: 1722028-2025-00191
• Device Sequence Number: 12184467
• Product Code: LKN
• UDI-Device Identifier: 05020583705005
• UDI-Public: 05020583705005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: 70500
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 03/10/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown