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

Model Number 12220

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Unspecified Respiratory Problem (4464)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: a used optia exchange set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally; ac, saline, and replacement fluids were returned attached to the spikes on the disposable set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident.No leaks, kit defects, or mis-assemblies were found.Witness and wear on the loop assembly were inspected to verify proper loop loading.Wear marks on the lower hex indicate the lower hex was loaded in a non-optimal position.The loading position indicates the rbc tubing was sitting on top of the plasma line and a partial or full occlusion may have been possible during the run.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure on a goodpastures wegeners patient had a cardiac event during a procedure.The patient gave a strong cough and there was a lot of blood in the ventilation tubing.The patient became agitated and was thrashing in the bed.The operator called the nurse in but the patient was sedated.The team came in and they started trying to suction and couldn't because there was blood.They increased the patients sedation.They decided to do a bronch and determined the patient respiratory and cardiac was compromised.The procedure had already been stopped at this point but the patient was still connected because the operator couldn't get close to the patient.The lines were clamped.Per the customer no premedications were given and the patient is in the icu and they are still in the code at the time of the report.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure on a goodpastures wegeners patient had a cardiac event during a procedure.The patient gave a strong cough and there was a lot of blood in the ventilation tubing.The patient became agitated and was thrashing in the bed.The operator called the nurse in but the patient was sedated.The team came in and they started trying to suction and couldn't because there was blood.They increased the patients sedation.They decided to do a bronch and determined the patient respiratory and cardiac was compromised.The procedure had already been stopped at this point but the patient was still connected because the operator couldn't get close to the patient.The lines were clamped.Per the customer no premedications were given and the patient is in the icu and they are still in the code at the time of the report.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a used optia exchange set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally; ac, saline, and replacement fluids were returned attached to the spikes on the disposable set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident.No leaks, kit defects, or mis-assemblies were found.Witness and wear on the loop assembly were inspected to verify proper loop loading.Wear marks on the lower hex indicate the lower hex was loaded in a non-optimal position.The loading position indicates the rbc tubing was sitting on top of the plasma line and a partial or full occlusion may have been possible during the run.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to 'complications of apheresis', reactions are common in subjects undergoing apheresis procedures.The risk of patient reactions is between (b)(4)%.Citation: kaplan, a.(2012).Complications of apheresis.Seminars in dialysis, 25(2), 152-158.Https://doi.Org/10.1111/j.1525-139x.2011.01026.X investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure on a goodpastures wegeners patient had a cardiac event during a procedure.The patient gave a strong cough and there was a lot of blood in the ventilation tubing.The patient became agitated and was thrashing in the bed.The operator called the nurse in but the patient was sedated.The team came in and they started trying to suction and couldn't because there was blood.They increased the patients sedation.They decided to do a bronch and determined the patient respiratory and cardiac was compromised.The procedure had already been stopped at this point but the patient was still connected because the operator couldn't get close to the patient.The lines were clamped.Per the customer no premedications were given and the patient is in the icu and they are still in the code at the time of the report.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in h.10.Investigation: a used optia exchange set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally; ac, saline, and replacement fluids were returned attached to the spikes on the disposable set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident.No leaks, kit defects, or mis-assemblies were found.Witness and wear on the loop assembly were inspected to verify proper loop loading.Wear marks on the lower hex indicate the lower hex was loaded in a non-optimal position.The loading position indicates the rbc tubing was sitting on top of the plasma line and a partial or full occlusion may have been possible during the run.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per scientific journal by sugimoto, et al, pulmonary-renal syndrome in wegener¿s granulomatosis, defined as a combination of diffuse pulmonary hemorrhage and glomerulonephritis, is a rare but serious complication that carries an extremely high fatality rate.Since this is disease-related, there is no evidence to indicate that the optia device caused or contributed to the patient¿s adverse event.Root cause: a root cause assessment was performed for this complaint.Based on the available information the root cause was likely due to the patient's pre-existing condition.Corrected investigation: the statement: according to 'complications of apheresis', reactions are common in subjects undergoing apheresis procedures.The risk of patient reactions is between (b)(4).Citation: kaplan, a.(2012).Complications of apheresis.Seminars in dialysis, 25(2), 152-158.Https://doi.Org/10.1111/j.1525-139x.2011.01026.X, is no longer applicable to this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• 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 ; 3032314970
• MDR Report Key: 12010402
• MDR Text Key: 256682322
• Report Number: 1722028-2021-00218
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2104153330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 04/14/2022; 04/22/2022
• Supplement Dates FDA Received: 04/18/2022; 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• 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): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 128 KG