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

Catalog Number 10220

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Per the article, "on further investigation, we found that there was an emergency change in brand of 5% human albumin solution from baxter ag (vienna, austria) to an indian brand seroalbumin (virchow biotech pvt.Ltd., andhra pradesh, india) due to the nonavailability of our routine supplies.Significant correlation was noticed between time of hemolysis and infusion of 5% albumin.Samples were taken from used normal saline, anticoagulant, and 5% albumin and were checked for quality and hemolysis test.About 5% albumin on centrifugation with red cells at 2000 rpm for 10 min showed pinkish discoloration.Biochemical analysis of 5% albumin solution showed sodium (na) concentration ¿ 22.5 mmol/l, potassium (k) ¿ 0, and chloride (cl) ¿ 6.0 mmol/l which confirmed our suspicion of hemolysis due to hyposmolality of albumin solution.Serum albumin levels were 4.0 g/dl which was less than 80% of total protein content (5.2 g/dl)." the case highlights the importance of root cause analysis of possible factors contributing to hemolysis or hemolytic reaction[1,2] during tpe [figure 1b].Quality control checks should be put on human albumin as well as other commercial solutions used in therapeutic apheresis procedures to ensure patient safety.Article citation: deepti, sachan, et.Al.2019.Hemolytic events during therapeutic plasma exchange: root cause analysis.Asian journal of transfusion science.Jan-jun; 13(1): 76¿78.2020https://www.Ncbi.Nlm.Nih.Gov/pm c/articles/pmc6580830/?report=printable investigation is in process.A follow-up report will be provided.

Event Description

Per the article, hemolytic events during therapeutic plasma exchange: root cause analysis in the asian journal of transfusion science, a patient had hemolysis occur during a therapeutic exchange procedure (tpe): "a (b)(6) year-old female presented with early graft rejection postliver transplant who was on regular tpe for past 2 weeks with 5% albumin and fresh-frozen plasma as replacement fluids.Procedure started with replacement fluid as 5% albumin and after 15 min alarm ¿ "red cell detected in plasma line" came, and hemolyzed plasma was noted in waste bag and centrifugation chamber.Procedure was paused as per instruction manual and was investigated for possible causes of hemolysis; when procedure was resumed with discontinuation of 5% albumin and fresh-frozen plasma units, the red cell detector kept on giving alarms, so procedure had to be discontinued at 0.5 plasma volume exchange.There was a drop of hemoglobin from 8.7 g/dl to 8.3 g/dl and total and direct bilirubin rose from 13.27 g/dl and 10.24 g/dl to 18.82 g/dl and 16.38 g/dl, respectively, which may be attributed to either due to graft dysfunction and/or hemolysis.However, the patient's vitals remained stable during the full procedure.Reddish discoloration was noted on centrifugation of postprocedure urine and plasma samples which was cleared by next morning.Repeat tpe procedure was performed next day which was completed uneventfully with no signs of hemolysis." the procedure was aborted.The patient was admitted in medical and liver transplant intensive care unit and had no previous clinical and laboratory features of hemolysis before starting the procedure.The report indicates that the hemolysis was due to a change in albumin solution products.Patient identifier and weight are not available at this time.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 e.1, h.6 and h.10.Investigation: the optia device serial number was not documented in the journal article, therefore a run data file (rdf) analysis could not be performed.The customer provided a photograph with the journal, which confirmed the waste bag displayed a reddish discoloration.The disposable lot number was not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: the customer provided a photograph with the journal, which confirmed the waste bag displayed a reddish discoloration.Per the article, "on further investigation, it was found that there was an emergency change in brand of 5% human albumin solution from baxter ag (vienna, austria) to an indian brand seroalbumin (virchow biotech pvt.Ltd., andhra pradesh, india) due to the nonavailability of our routine supplies.Significant correlation was noticed between time of hemolysis and infusion of 5% albumin.Laboratory investigation for hemolysis workup showed reddish discoloration in plasma color in both patients post procedure samples.Samples were taken from used normal saline, anticoagulant, and 5% albumin and were checked for quality and hemolysis test.About 5% albumin on centrifugation with red cells at 2000 rpm for 10 min showed pinkish discoloration.Biochemical analysis of 5% albumin solution showed sodium (na) concentration ¿ 22.5 mmol/l, potassium (k) ¿ 0, and chloride (cl) ¿ 6.0 mmol/l which confirmed our suspicion of hemolysis due to hyposmolality of albumin solution.Serum albumin levels were 4.0 g/dl which was less than 80% of total protein content (5.2 g/dl)." investigation is in process.A follow up report will be provided.

Event Description

Patient information is located on the aer tab.Patient ids and weights were unavailable.The author was contacted but has since left this hospital and no longer has access to the information.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: based on terumobct internal medical review conclusion, it can be concluded that the hypoosmolality of the albumin solution used as fluid replacement likely caused hemolysis of the patient red blood cells.Root cause: based on the information in the journal article, the root cause of the hemolysis was due to a change in albumin solution products.The replacement albumin showed a failure of quality control with low sodium and albumin content in the bottle.Biochemical analysis of 5% albumin solution showed sodium (na) concentration ¿ 22.5 mmol/l, potassium (k) ¿ 0, and chloride (cl) ¿ 6.0 mmol/l which confirmed our suspicion of hemolysis due to hypoosmolality of albumin solution.Serum albumin levels were 4.0 g/dl which was less than 80% of total protein content (5.2 g/dl).

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9910889
• MDR Text Key: 187099326
• Report Number: 1722028-2020-00140
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2020

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 06/02/2020; 03/11/2021; 06/07/2021
• Supplement Dates FDA Received: 06/05/2020; 03/19/2021; 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00058 YR