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	Local Reaction (2035); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/1993
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the article "complications of therapeutic plasma exchange: a recent assessment" by daniel couriel and robert weinstein: four patients (6.4%) experienced severe complications (table vi), all of which were related to the use of venous access catheters.These complications included staphylo coccal bacteremia from an infected catheter, necessitating an additional 4 weeks of hospitalization for antibiotic therapy, a sternocleidcimastoid hematoma following placement of an internal jugular catheter, and an apical pneumothorax during placement of a subclavian catheter.The latter complication resolved spontaneously without requiring a chest tube.The fourth severe (catheter-related) complication occurred in an elderly woman with myasthenia gravis who was malnourished owing to swallowing dysfunction.Her anticholinesterase medication had caused her to have chronic diarrhea.On admission she was emaciated and mildly vitamin k deficient with a prothrombin time of 14 seconds (control 12 seconds) and platelet count of 265 x lo'/liter.Placement of a subclavian catheter for tpe was seemingly uneventful, and she underwent an uncomplicated first tpe for 1.5 plasma volumes with 5% albu her plasma fibrinogen level fell to 100 mg/dl and her prothrombin time remained minimally elevated.Over the next 2 days she developed symptomatic anemia from a hemopneumothorax and required support with packed red blood cells and cryoprecipitate.Apparently an apical bulla was punctured during placement of the subclavian catheter and, with fibrinogen depletion from the initial plasma exchange, she experienced hemostatic failure.Subsequent tpe included cryoprecipitate support with no further bleeding.Two deaths occurred in association with tpe (table vii).One patient exsanguinated from an arterial laceration that occurred during the attempt to place a subclavian catheter.She did not survive to undergo tpe.This patient had myasthenia gravis and was malnourished.The second fatality was a woman with postpartum thrombotic microangiopathy who presented with headache, rapidly deteriorating renal function, hypertension, anemia, and thrombocytopenia.She suffered a fatal cerebral hemorrhage at the conclusion of her first tpe.The procedure was performed via antecubital access and had been un eventful, not resulting in hypofibrinogenemia, coagulation abnormalities, further lowering of the platelet count, or fluctuations of blood pressure.The hemorrhage was felt to have been related to her underlying disease.This report is being filed as a patient death was listed, 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 is in process.A follow-up report will be provided.Citation: couriel, d., & weinstein, r.(1994).Complications of therapeutic plasma exchange: a recent assessment.Journal of clinical apheresis, 9(1), 1¿5.Https://doi.Org/10.1002/jca.2920090102.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.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 while there were adverse events associated with tpe, all procedures were performed using one of the following: fenwal cs-3000 plus , cobe spectra, pcs ultralite , autopheresis c with no identifiable information to link the adverse events to a tbct procedure/product.No further reporting will be provided as this does not represent a reportable event.Citation: couriel, d., & weinstein, r.(1994).Complications of therapeutic plasma exchange: a recent assessment.Journal of clinical apheresis, 9(1), 1¿5.Https://doi.Org/10.1002/jca.2920090102.
Event or Problem Description
Per the article "complications of therapeutic plasma exchange: a recent assessment" by daniel couriel and robert weinstein: four patients (6.4%) experienced severe complications (table vi), all of which were related to the use of venous access catheters.These complications included staphylo coccal bacteremia from an infected catheter, necessitating an additional 4 weeks of hospitalization for antibiotic therapy, a sternocleidcimastoid hematoma following placement of an internal jugular catheter, and an apical pneumothorax during placement of a subclavian catheter.The latter complication resolved spontaneously without requiring a chest tube.The fourth severe (catheter-related) complication occurred in an elderly woman with myasthenia gravis who was malnourished owing to swallowing dysfunction.Her anticholinesterase medication had caused her to have chronic diarrhea.On admission she was emaciated and mildly vitamin k deficient with a prothrombin time of 14 seconds (control 12 seconds) and platelet count of 265 x lo'/liter.Placement of a subclavian catheter for tpe was seemingly uneventful, and she underwent an uncomplicated first tpe for 1.5 plasma volumes with 5% albu her plasma fibrinogen level fell to 100 mg/dl and her prothrombin time remained minimally elevated.Over the next 2 days she developed symptomatic anemia from a hemopneumothorax and required support with packed red blood cells and cryoprecipitate.Apparently an apical bulla was punctured during placement of the subclavian catheter and, with fibrinogen depletion from the initial plasma exchange, she experienced hemostatic failure.Subsequent tpe included cryoprecipitate support with no further bleeding.Two deaths occurred in association with tpe (table vii).One patient exsanguinated from an arterial laceration that occurred during the attempt to place a subclavian catheter.She did not survive to undergo tpe.This patient had myasthenia gravis and was malnourished.The second fatality was a woman with postpartum thrombotic microangiopathy who presented with headache, rapidly deteriorating renal function, hypertension, anemia, and thrombocytopenia.She suffered a fatal cerebral hemorrhage at the conclusion of her first tpe.The procedure was performed via antecubital access and had been un eventful, not resulting in hypofibrinogenemia, coagulation abnormalities, further lowering of the platelet count, or fluctuations of blood pressure.The hemorrhage was felt to have been related to her underlying disease.This report is being filed as a patient death was listed, 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.

• 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: 22879674
• Report Number: 1722028-2025-00192
• Device Sequence Number: 13355070
• Product Code: LKN
• UDI-Device Identifier: 05020583705005
• UDI-Public: 05020583705005
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K900105C
• 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: 07/25/2025
• 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: Other
• Patient Sex: Unknown