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

Catalog Number	70700
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a red blood cell exchange (rbcx) an operator found air bubbles in the return air chamber during prime on a cobe spectra device.They stated that the chamber air could not be removed from the return section.Per the customer, all luer connections were not tight, the blood diversion pouch was not inflated with air, no air was being drawn in through the ac line or filter, and there was no clotting in the set.The patient was not connected at the time therefore, no medical intervention was required.The customer declined to provide patient id.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
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.Per follow up, it was found that air was not past the point of last detection and there was no air returned to the patient.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that during a red blood cell exchange (rbcx) an operator found air bubbles in the return air chamber during prime on a cobe spectra device.They stated that the chamber air could not be removed from the return section.Per the customer, all luer connections were not tight, the blood diversion pouch was not inflated with air, no air was being drawn in through the ac line or filter, and there was no clotting in the set.The patient was not connected at the time therefore, no medical intervention was required.The customer declined to provide patient id.The collection set is not available for return because it was discarded by the customer.

• Brand Name: COBE SPECTRA
• Common Device Name: COBE SPECTRA RBCX SET
• Manufacturer (Section D): TEURMO 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: 20641476
• Report Number: 1722028-2024-00461
• Device Sequence Number: 7423039
• Product Code: GKT
• UDI-Device Identifier: 05020583707009
• UDI-Public: 05020583707009
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: BK040086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Catalogue Number: 70700
• Device Lot Number: 08G15205
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 70 KG