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

Model Number 12320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematuria (2558)

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: the clinical specialist revealed that the person who experienced the lipothymia and hematuria was a healthy donor who was donating cells for a lymphoblastic leukemia patient.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported following a donation procedure with no complications, the donor experienced lipothymia and hematuria.The physician at the customer site assessed the donor and ordered control of vital signs, intake of abundant oral fluids and observation.No medical intervention was required for this event and the donor is stable.The donor was observed in the clinic for two hours.The physician called the donor later that night and the patient reported feeling well and was urinating normally.Donor information is not available at this time.The collection set is not available for return because it was discarded by the customer.

Event Description

Patient gender and weight were obtained from the run data file.

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.Review of the rdfand associated images for this procedure did not indicate a clear root cause for the lipothymia and hematuria experienced by the patient.The aim images were clear and clean and showed no signs of clumping.The pumps operated in their designed ranges.The pressures and levels in the set were well within the operating expectations.The device 1p02844 operated as intended and is safe for continued use.However, inlet and return pressure alarms were generated at an unusually high rate for this procedure.While a couple access alarms should not dramatically impact the procedure, multiple access alarms can have a big impact on the procedure and clumping.Pressure alarms can contribute to the severity of clumping during a procedure as they cause the pumps to pause and the system to re-establish the interface, which in turn affects how well the buffy coat is separated and the flow of fluids through the set.The system is not efficiently moving blood through the set and stagnant blood tends to contribute to platelet clumping so the product entering the collect bag is may contain microaggregates and platelet clumps.Consequently, minimizing pump pauses allows the system to establish the interface quickly and adequately separate the blood to maximize the amount blood being processed.Avoiding conditions that cause pressure alarms and the pumps to pause will result in a more efficient procedure and less platelet clumping.The most common source of pressure alarms is when the inlet flow rate is set too high for the given patient/donor access or the patient/donor access is not properly positioned.In response to these alarms, it is suggested to lower the inlet flow rate and ensure the access is positioned such that flow is not obstructed.In the procedures with excessive alarms, it may have helped to decrease the inlet flow rate further and earlier to minimize the occurrence of the alarms.Ensuring the patient/donor access is appropriately sized, nothing is blocking the access, the inlet flow rate is not too high, and generally controlling access issues is important as these can greatly contribute to the success of a procedure.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, a.2, h.6 and h.10.Investigation: per the article by m.Mcdonald et al, assessment of microscopic hematuria in adults, the prevalence of asymptomatic microscopic hematuria in adults ranges from 0.19 to 21 percent.The range is wide because of differing definitions of clinically significant microscopic hematuria and varying ages of the study populations.Urine normally contains a few red blood cells, and microscopic hematuria generally is defined as one to 10 red blood cells per high-power field of urine sediment.The american urological association (aua) defines clinically significant microscopic hematuria as three or more red blood cells per high-power field on microscopic evaluation of urinary sediment from two of three properly collected urinalysis specimens.Each laboratory, however, establishes its own thresholds based on the method of detection used and in reference to healthy persons as controls.Urine dipstick evaluation may be misleading because it lacks the ability to distinguish red blood cells from myoglobin or hemoglobin.Therefore, a positive finding of microscopic hematuria on urinary dipstick testing requires follow-up examination by microscopic technique to confirm the presence of red blood cells.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, syncope, loss of bowel and bladder control, convulsions, or a combination of these.The optia essentials guide (page 16) advises the operator of possible adverse effects of apheresis procedures and to be prepared to take appropriate action should any reactions occur.Some previously reported reactions are: ¿ anxiety ¿ headache ¿ light-headedness ¿ digit and/or facial paresthesia ¿ fever ¿ chills ¿ hematoma ¿ hyperventilation ¿ nausea and vomiting ¿ syncope (fainting) ¿ urticaria ¿ hypotension ¿ allergic reactions.A disposable history search found no other reports of similar issues associated with lot 2010223130.The device history record was reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.The urine sediment was not analyzed to determine whether or not there was hemolysis detected in the donor¿s urine (hemoglobinuria).Root cause: a definitive root cause for the hematuria was unable to be determined.Possible causes of hematuria include but are not limited to: - an unknown donor disease or condition, such as urinary tract infection, kidney problems including infection, stones, disease, or injury; or an enlarged prostate - certain medications, such as blood thinners, aspirin and other pain relievers, and antibiotics - strenuous exercise - although the aim images determined there was no hemolysis observed in the connector during the run, it is possible there was an occlusion/clot or unidentified manufacturing defect in the disposable set causing shear induced hemolysis resulting in the observed hematuria.Other possible root causes include but are not limited to: - pinched inlet and/or return lines resulting in rbcs exposed to pressure drop in inlet and/or return lines.- inlet or return needle replaced with smaller diameter resulting in rbcs exposed to pressure drop in the inlet/return line.A definitive root cause for the lipothymia was unable to be determined.Possible causes include but are not limited to: - donor's physiology - donor's apprehension about apheresis procedure (nervousness) - machine settings, length of procedure, or ac infusion rate too fast for the donor.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11771661
• MDR Text Key: 251362178
• Report Number: 1722028-2021-00171
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2021

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: 10/01/2022
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2010223130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 06/10/2021; 06/23/2021
• Supplement Dates FDA Received: 06/16/2021; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACD LOT: 20063035
• Patient Outcome(s): Other
• Patient Age: 00029 YR
• Patient Weight: 69