MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. 0.8% SURG 3X10ML; REAGENT RED BLOOD CELLS

Model Number	6902316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/03/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation summary: customer reported a patient death due to negative antibody screening results.Testing was performed on three ortho vision analyzers on (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021 and negative antibody screening results were confirmed.Cold agglutination studies were performed and a cold antibody was identified including a positive autocontrol which became negative at 30 degrees c.Patient with history or breast cancer and mitral regurgitation of pulmonary vein, was taken to surgery on (b)(6) 2021.After a massive transfusion protocol was activated, the patient expired during surgery.Customer indicates that the patient was already in demise before any transfusion and that the patient's death was not transfusion related.(b)(4).
Event or Problem Description
Mxp2493870; ra600634 customer reported a patient death due to negative antibody screening results.Testing was performed on three ortho vision analyzers on (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021 and negative antibody screening results were confirmed.Cold agglutination studies were performed and a cold antibody was identified including a positive autocontrol which became negative at 30 degrees c.Patient with history or breast cancer and mitral regurgitation of pulmonary vein, was taken to surgery on (b)(6) 2021.After a massive transfusion protocol was activated, the patient expired during surgery.Customer indicates that the patient was already in demise before any transfusion and that the patient's death was not transfusion related.Ortho investigation: batch record review and a complaint review were performed.Retain samples had already expired.All results were as expected.The order reports for testing performed on the customer's ortho vision id-mts analyzers were requested but were not provided by the customer.Ortho's medical safety officer was consulted on this case and provided the following response: based on the available information, multiple type and screening tests were done for this patient and generated o positive and antibody screening negative results.However, cold reactivity was detected using ortho method and positive antibody screening was also obtained using a non-ortho method and an anti-p1 was identified for this patient.Anti-p1 is typically a clinically insignificant igm antibody that does not react at temperatures >25 °c.The patients received multiple crossmatched and prewarmed red blood cell units on (b)(6) 2021.On (b)(6) , the patient was in surgery later died.No information to suggest the patient experienced a hemolytic transfusion reaction when received the massive transfusion during the surgery.It is highly unlikely patient's death was caused by the anti-p1 antibody.

• Brand Name: 0.8% SURG 3X10ML
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16215744
• Report Number: 0002250051-2023-00037
• Device Sequence Number: 6033124
• Product Code: QHT
• UDI-Device Identifier: 10758750007660
• UDI-Public: 10758750007660
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2023

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 Model Number: 6902316
• Device Catalogue Number: 6902316
• Device Lot Number: MULTIPLE LOTS: VSS297, VSS302
• 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: 01/05/2023
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown