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

Model Number 12220

Device Problems Backflow (1064); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.Investigation: the following calculation was performed for this event: 185 saline used for priming, 40 ml blood warmer= 225 ml 1000 saline -225 saline for priming and blood warmer = 775 tbv 5387- 325 ml= 5062 5062:5387=.939x 100= 93.9 % fb calculate final fluid balance (including saline bolus): 94% investigation is in process, a follow--up report will be provided.

Event Description

The customer reported that 9 minutes into a therapeutic plasma exchange (tpe) procedure on a patient with myasthenia gravis, she noticed blood backing back up into the saline line.The machine was paused and the customer contacted tbct customer support.Customer support asked the status of the saline roller clamps, and the customer indicated that one was open and closed it.They continued the procedure.Upon follow-up, it was indicated that they pushed 1 liter of saline per the doctor's orders as the patient's blood pressure was 90/50.The patient also had lunch and snacks during the procedure.Per the customer, the patient is stable and had finished the procedure.The disposables 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 following calculation was performed for this event: 185 saline used for priming, 40 ml blood warmer= 225 ml 1000 saline -225 saline for priming and blood warmer = 775 tbv 5387- 325 ml= 5062 5062:5387=.939x 100= 93.9 % fb calculate final fluid balance (including saline bolus): 94% photographs were submitted in lieu of the disposable set to aid in the investigation.The photographs include pictures that confirm the saline bag was 1000ml.The volume left in the saline bag with the blood that backed up into it include is confirmed as 1100ml.Blood is confirmed in the saline bag as well as the saline drip chamber and line.Pictures confirm that the return saline line roller clamp (blue) is closed as well as the blue pinch clamp on the return line.There is a hemostat on the saline line below the drip chamber, and above the cassette.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Correction: terumo blood and cell technologies¿ clinical specialist reminded the customer to check and make sure that the saline roller clamps were closed.The customer verified and acknowledged that the roller clamp was inadvertently left open.Retraining occurred at the time of the error via the phone through the clinical specialist.Root cause: a root cause assessment was performed for this complaint.The reported hypotension is a common side effect of therapeutic apheresis procedures.It is typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.The blood diverted to the saline bag was the result of an operator error.Specifically, the operator failed to follow the screen prompts to fully close the blue saline roller clamp, and open the blue return pinch clamp.As a result, the returned blood was pumped into the saline bag instead of returning to the patient.

Event Description

The customer reported that 9 minutes into a therapeutic plasma exchange (tpe) procedure on a patient with myasthenia gravis, she noticed blood backing back up into the saline line.The machine was paused and the customer contacted tbct customer support.Customer support asked the status of the saline roller clamps, and the customer indicated that one was open and closed it.They continued the procedure.Upon follow-up, it was indicated that they pushed 1 liter of saline per the doctor's orders as the patient's blood pressure was 90/50.The patient also had lunch and snacks during the procedure.Per the customer, the patient is stable and had finished the procedure.The customer declined to provide patient identifier and age.The disposables 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 b.5, d.4, h.4, h.6 and h.10.Investigation: the following calculation was performed for this event: 185 saline used for priming, 40 ml blood warmer= 225 ml 1000 saline -225 saline for priming and blood warmer = 775 tbv 5387- 325 ml= 5062 5062:5387=.939x 100= 93.9 % fb calculate final fluid balance (including saline bolus): 94% photographs were submitted in lieu of the disposable set to aid in the investigation.The photographs include pictures that confirm the saline bag was 1000ml.The volume left in the saline bag with the blood that backed up into it include is confirmed as 1100ml.Blood is confirmed in the saline bag as well as the saline drip chamber and line.Pictures confirm that the return saline line roller clamp (blue) is closed as well as the blue pinch clamp on the return line.There is a hemostat on the saline line below the drip chamber, and above the cassette.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow--up report will be provided.

Event Description

The customer reported that 9 minutes into a therapeutic plasma exchange (tpe) procedure on a patient with myasthenia gravis, she noticed blood backing back up into the saline line.The machine was paused and the customer contacted tbct customer support.Customer support asked the status of the saline roller clamps, and the customer indicated that one was open and closed it.They continued the procedure.Upon follow-up, it was indicated that they pushed 1 liter of saline per the doctor's orders as the patient's blood pressure was 90/50.The patient also had lunch and snacks during the procedure.Per the customer, the patient is stable and had finished the procedure.The customer declined to provide patient identifier and age.The disposables 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: 13686092
• MDR Text Key: 286739495
• Report Number: 1722028-2022-00078
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2110203230
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2021
• 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; Other
• Patient Sex: Female