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

Catalog Number 12220

Device Problems Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they were receiving 'cells were detected in plasma line from centrifuge' alarm during a red blood cell exchange (rbcx) procedure on a spectra optia device.The alarm occurred on the second unit of rbcs; the plama was a red color.The customer confirmed that the correct fluids were hanging.There was a 0.9% saline drip going for the procedure.The customer contacted the physician before continuing the run.The physician decided to discontinue the treatment.The patient admitted for observation.The patient was stable following the event and was discharged the next day.The following tests were performed: post transfusion dat & hemolysis, cbc, cmp, post fractionation, ua, covid test.The results were negative.The patient had another successful rbcx done on the following monday.The customer declined to provide patient identifier.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the device history record was reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10.Corrected information is provided in e.3.Investigation: the procedure was discontinued and the patient was admitted to the hospital for observation and testing.Post transfusion dat & hemolysis, cbc, cmp, post fractionation, ua, covid test.The test results were negative.The negative dat rule out incompatible donor replacement rbcs as a root cause for the hemolysis.The metabolic, fractionation and urine analysis all ruled out hemolysis as a patient¿s pre-existing condition.They did not perform a direct plasma free hemoglobin test on the second rbc replacement fluid so that it is possible that they were using a unit of hemolyzed blood.Root cause: a definitive root cause for the discolored plasma could not be determined.Possible causes include but are not limited to: the second unit of rbc replacement unit contained hemolyzed blood - a misload of the disposable set - occlusion in the disposable set tubing - partial flash, bad seam weld, and/or assembly error on the channel connector.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10662503
• MDR Text Key: 214151063
• Report Number: 1722028-2020-00466
• 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,Followup
• Report Date: 10/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2007073130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 06/22/2021; 08/18/2022
• Supplement Dates FDA Received: 07/06/2021; 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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 Age: 15 YR
• Patient Sex: Female
• Patient Weight: 50 KG