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

Catalog Number 12220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2023

Event Type  Injury  

Event Description

The customer reported that a patient received a blood transfusion after a red blood cell exchange (rbcx).Patient information and outcome are unknown at this time.The customer failed to respond to multiple attempts to obtain essential information.The collection set is not available for return because it was discarded by the customer.

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.

Manufacturer Narrative

Investigation: the customer failed to respond to request for disposable lot number.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The run data file (rdf) was analyzed for this event.All systems remained in place and the appropriate alarms were raised.The device was found to be performing as intended.The final fluid balance and target hematocrit were achieved as programmed a root cause assessment was performed for the adverse event that necessitated transfusion of blood products post rbcx procedure.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * patient¿s underlying disease state operator replace fluid hematocrit entry error resulted in patient with end hematocrit lower than expected.

Event Description

The customer reported that a patient received a blood transfusion after a red blood cell exchange (rbcx).The customer failed to respond to multiple attempts to obtain essential information such as id, age and outcome.Donor gender and weight were obtained from the run data file (rdf).The collection set is not available for return because it was discarded by the customer.

• 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: 18924875
• MDR Text Key: 337916812
• Report Number: 1722028-2024-00084
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• 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
• Patient Sex: Female
• Patient Weight: 70 KG