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

Catalog Number 12220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 05/16/2017

Event Type  malfunction  

Event Description

The journal article, 'therapeutic plasma exchange causing (not curing) hemolysis' discusses a case of a patient undergoing therapeutic plasma exchange (tpe).Per the article, at the beginning of the patient's 4th of 7 tpe procedures, the operator noted an altered appearance to the waste plasma being removed.The procedure was immediately discontinued (251 ml of blood with 10 ml of anticoagulant had been processed) without reinfusion of extracorporeal blood.Since only 11 ml of blood had been returned and the clinical status and vital signs of the patient (blood pressure 142/81; pulse 81 beats/minute) were unchanged in the period immediately after discontinuation of the initial procedure, laboratory studies for hemolysis (direct coomb¿s test, lactate dehydrogenase level, haptoglobin level, bilirubin level, etc.) were foregone.The patient identifier is not available at this time.The exchange set is not available for return for evaluation.

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process.A follow up report will be provided.Article citation: graham, b.C., burgstaler, e.A., winters, j.L.Therapeutic plasma exchange causing (not curing) hemolysis.J.Clinapheresis 33(3):393-395 2018.

Manufacturer Narrative

Investigation: since this is a journal published in 2017 without unknown procedural date, the lot number was not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The authors included three photos in the publication and the findings are as follows: a, plasma demonstrating hemolysis within the cassette tubing.B, cassette tubing from second tpe procedure after switching instruments and reestablishing peripheral vascular access.Note the normal appearing plasma without evidence of hemolysis.C, plasma demonstrating hemolysis collected from the ¿waste¿ plasma bag after discontinuation of the tpe procedure.Centrifugation of the sample failed to demonstrate any red blood cells within the sample per the article, "at the time tpe was initiated, the patient was receiving only glucocorticoids and interferon beta for multiple sclerosis.This tpe was number 4 of 7 planned procedures (tpe was performed every other day [skipping weekends] over 16 days).The three previous procedures had been tolerated well without incident.Per departmental protocol, 1.5 plasma volumes (3034 ml) had been exchanged in the previous procedures utilizing the standard anticoagulant mixture consisting of 1000 ml acid-citrate-dextrose solution a (acda) with 10000 units of heparin at an anticoagulant: blood ratio of 26:1.Standard peripheral venous access utilizing a 16-gauge steel needle for inlet access and a flexible 18- gauge needle for return access in the opposite arm with 12-fr catheters.These parameters from the previous procedures were utilized in the current procedure.Peripheral venous access was difficult to establish with multiple inlet access alarms in the early part of the procedure due to poor flow through the ¿draw¿ line.The patient¿s apheresis nurse vigilantly noted an altered appearance to the initial ¿waste¿ plasma coursing through the pump cassette and into the ¿waste bag¿ (figure 1a).The procedure was immediately discontinued (251 ml of blood with 10 ml of anticoagulant had been processed) without reinfusion of extracorporeal blood.A new apheresis instrument was prepared for the patient, new peripheral venous access was established, and the procedure was restarted and completed without incident (figure 1b).A systematic search for osmotic, thermal, and mechanical causes of hemolysis was undertaken.Hypotonic solutions have been shown to cause osmotic lysis of red cells in the classic experiments conducted by parpart et al.3 in our patient, inspection of the replacement/priming/anticoagulant fluids demonstrated that the standard fluids of isotonic 5% human albumin solution, 0.9% nacl (normal) saline, and acda had been appropriately selected and administered excluding osmotic lysis.No blood warmer was used, and close inspection of the centrifuge unit (by means of manual examination of the centrifuge housing, centrifuge ¿bowl,¿ and associated tubing) for increased temperature was negative excluding thermal causes as the source of hemolysis.Mechanical destruction of red cells in an apheresis instrument is caused by shear forces that exceed 1000¿1500 dynes/cm2.These shear forces can be due to turbulent flow of blood because of kinked/pinched tubing or an improperly loaded centrifuge; pump rollers that are not free-moving secondary to fouling with plasma or albumin can likewise cause mechanical destruction of red cells.In our case, the instrument was examined by the apheresis nurse and one of the authors (e.B.) and revealed no problems with the tubing, centrifuge, or mechanical rollers.Examination of the apheresis cassette, however, revealed an interesting finding: the pre-centrifuge filter within the kit cassette was laden with gross blood clots that occluded the filter (figure 2).In the context of multiple access alarms and difficulty establishing peripheral venous access, these spontaneous blood clots likely formed in the draw line at the needle site¿a conclusion supported by previously successful tpe procedures utilizing the same anticoagulant mixture and ratio.As these aggregates occluded the pre-centrifuge filter, the draw pressure created a state of turbulent flow and shear stress within the filter that resulted in significant red cell hemolysis." root cause: a root cause assessment was performed for this complaint.According to the authors, "in our case, the instrument was examined by the apheresis nurse and one of the authors (e.B.) and revealed no problems with the tubing, centrifuge, or mechanical rollers.Examination of the apheresis cassette, however, revealed an interesting finding: the pre-centrifuge filter within the kit cassette was laden with gross blood clots that occluded the filter.In the context of multiple access alarms and difficulty establishing peripheral venous access, these spontaneous blood clots likely formed in the draw line at the needle site¿a conclusion supported by previously successful tpe procedures utilizing the same anticoagulant mixture and ratio.As these aggregates occluded the pre-centrifuge filter, the draw pressure created a state of turbulent flow and shear stress within the filter that resulted in significant red cell hemolysis." based on the available information a definitive root cause for clotting could not be determined but it is likely due to one or a combination of the possible causes listed below: * use of anticoagulant mixture with heparin at a high anticoagulant: blood ratio of 26:1 which was inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.* activation of platelets as a result of the patient's physiology.Article citation: graham, b.C., burgstaler, e.A., winters, j.L.Therapeutic plasma exchange causing (not curing) hemolysis.J.Clinapheresis 33(3):393-395 2018.

Event Description

The journal article, 'therapeutic plasma exchange causing (not curing) hemolysis' discusses a case of a patient undergoing therapeutic plasma exchange (tpe).Per the article, at the beginning of the patient's 4th of 7 tpe procedures, the operator noted an altered appearance to the waste plasma being removed.The procedure was immediately discontinued (251 ml of blood with 10 ml of anticoagulant had been processed) without reinfusion of extracorporeal blood.Since only 11 ml of blood had been returned and the clinical status and vital signs of the patient (blood pressure 142/81; pulse 81 beats/minute) were unchanged in the period immediately after discontinuation of the initial procedure, laboratory studies for hemolysis (direct coomb¿s test, lactate dehydrogenase level, haptoglobin level, bilirubin level, etc.) were foregone.This is a journal published in 2017 without unknown procedural date.A request for specific patient information is not feasible.The exchange set is not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10.Investigation: since this is a journal published in 2017 without unknown procedural date, the lot number was not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The authors included three photos in the publication and the findings are as follows: a, plasma demonstrating hemolysis within the cassette tubing.B, cassette tubing from second tpe procedure after switching instruments and reestablishing peripheral vascular access.Note the normal appearing plasma without evidence of hemolysis.C, plasma demonstrating hemolysis collected from the ¿waste¿ plasma bag after discontinuation of the tpe procedure.Centrifugation of the sample failed to demonstrate any red blood cells within the sample investigation is in process.A follow up report will be provided.Article citation: graham, b.C., burgstaler, e.A., winters, j.L.Therapeutic plasma exchange causing (not curing) hemolysis.J.Clinapheresis 33(3):393-395 2018.

Event Description

The journal article, 'therapeutic plasma exchange causing (not curing) hemolysis' discusses a case of a patient undergoing therapeutic plasma exchange (tpe).Per the article, at the beginning of the patient's 4th of 7 tpe procedures, the operator noted an altered appearance to the waste plasma being removed.The procedure was immediately discontinued (251 ml of blood with 10 ml of anticoagulant had been processed) without reinfusion of extracorporeal blood.Since only 11 ml of blood had been returned and the clinical status and vital signs of the patient (blood pressure 142/81; pulse 81 beats/minute) were unchanged in the period immediately after discontinuation of the initial procedure, laboratory studies for hemolysis (direct coomb¿s test, lactate dehydrogenase level, haptoglobin level, bilirubin level, etc.) were foregone.The patient identifier is not available at this time.The exchange set is not available for return for evaluation.

• 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
• MDR Report Key: 15894570
• MDR Text Key: 307897352
• Report Number: 1722028-2022-00386
• Device Sequence Number: 1
• Product Code: GKT
• 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: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2022

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 Catalogue Number: 12220
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 01/09/2023; 01/18/2023
• Supplement Dates FDA Received: 01/16/2023; 01/27/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 25 YR
• Patient Sex: Male
• Patient Weight: 97 KG