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

Model Number 10220

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

Patient Problem Hemolysis (1886)

Event Date 12/04/2022

Event Type  malfunction  

Event Description

Per journal article "hemolysis during therapeutic plasma exchange: a rare phenomena" by kakkar, b.,melinkeri, s.,narawade, s.,ketkar, s.,kulkarni, s.Immediately after starting the albumin infusion, the plasma waste bag showed reddish discoloration and the machine gave a hemolysis alarm at approximately 200 ml of 5% albumin infusion.The procedure was paused to check for possible causes of hemolysis (patient, equipment, procedure, drug or replacement fluid).After consulting with the treating physician, procedure was re-started and completed using ffp as the replacement fluid.There were no signs/ symptoms, change in vital parameters or laboratory parameters suggestive of acute hemolytic transfusion reaction.The following day session 2 of tpe (post-bmt) was also performed using 500 ml normal saline and ffp only as replacement fluid.No adverse events noted during this session.The collection set is not available for return because it was discarded by the customer.Patient weight and id were not included in the article and therefore, are not available.

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.Kakkar b, melinkeri s, narawade s, ketkar s, kulkarni s.Hemolysis during therapeutic plasma exchange: a rare phenomena.Transfusion medicine.2023; 33(3):268-270.Doi:10.1111/tme.12958.

Manufacturer Narrative

Investigation: since this was a journal publication to understand hemolysis as a known complication in patients undergoing plasma exchange, the lot numbers were not requested; 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.Kakkar b, melinkeri s, narawade s, ketkar s, kulkarni s.Hemolysis during therapeutic plasma exchange: a rare phenomena.Transfusion medicine.2023; 33(3):268-270.Doi:10.1111/tme.12958.

Event Description

Per journal article "hemolysis during therapeutic plasma exchange: a rare phenomena" by kakkar, b.,melinkeri, s.,narawade, s.,ketkar, s.,kulkarni, s.Immediately after starting the albumin infusion, the plasma waste bag showed reddish discoloration and the machine gave a hemolysis alarm at approximately 200 ml of 5% albumin infusion.The procedure was paused to check for possible causes of hemolysis (patient, equipment, procedure, drug or replacement fluid).After consulting with the treating physician, procedure was re-started and completed using ffp as the replacement fluid.There were no signs/ symptoms, change in vital parameters or laboratory parameters suggestive of acute hemolytic transfusion reaction.The following day session 2 of tpe (post-bmt) was also performed using 500 ml normal saline and ffp only as replacement fluid.No adverse events noted during this session.The collection set is not available for return because it was discarded by the customer.Patient weight and id were not included in the article and therefore, are not available.

Event Description

Per journal article "hemolysis during therapeutic plasma exchange: a rare phenomena" by kakkar, b.,melinkeri, s.,narawade, s.,ketkar, s.,kulkarni, s.Immediately after starting the albumin infusion, the plasma waste bag showed reddish discoloration and the machine gave a hemolysis alarm at approximately 200 ml of 5% albumin infusion.The procedure was paused to check for possible causes of hemolysis (patient, equipment, procedure, drug or replacement fluid).After consulting with the treating physician, procedure was re-started and completed using ffp as the replacement fluid.There were no signs/ symptoms, change in vital parameters or laboratory parameters suggestive of acute hemolytic transfusion reaction.The following day session 2 of tpe (post-bmt) was also performed using 500 ml normal saline and ffp only as replacement fluid.No adverse events noted during this session.The collection set is not available for return because it was discarded by the customer.Patient weight and id were not included in the article and therefore, are not available.

Manufacturer Narrative

This report is being filed to provide investigation: since this was a journal publication to understand hemolysis as a known complication in patients undergoing plasma exchange, the lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Regarding terumo bct product, spectra optia, there was one adverse event reported.¿immediately after starting the albumin infusion, [during a tpe procedure,] the plasma waste bag showed reddish discoloration and machine gave a hemolysis alarm at approximately 200 ml of 5% albumin infusion¿.The authors did note that ¿root cause analysis was performed to determine the cause of hemolysis during tpe session 1 (post bmt)¿ ¿ the authors observed ¿a significant correlation between time of hemolysis and 5% albumin infusion: (i) no hemolysis noted during tpe sessions performed as part of desensitisation protocol, (ii) immediate hemolysis noted after 5% albumin infusion during the first session post-bmt and (iii) no hemolysis noted in the second session post-bmt.¿ root cause analysis was performed by the authors and it was concluded ¿that hemolysis was seen due to hyposmolality of albumin solution¿ the biochemical analysis performed of the albumin used failed the quality analysis as it showed low sodium content, however, the albumin content was adequate.¿ kakkar b, melinkeri s, narawade s, ketkar s, kulkarni s.Hemolysis during therapeutic plasma exchange: a rare phenomena.Transfusion medicine.2023; 33(3):268-270.Doi:10.1111/tme.12958 root cause: a root cause assessment for the hemolysis was performed for this journal article.Based on the conclusions drawn by the operators, the root cause of the hemolysis was due to the hyposmolality of albumin solution.As per the guidelines available for quality control testing of human albumin solution by national institute of biologicals (nib) 96% of the protein content should be albumin with sodium levels between 130 and 160 mmol/l.The biochemical analysis performed of the albumin used failed the quality analysis as it showed low sodium content, however, the albumin content was adequate.Therefore, based on the information available, the root cause of the reported adverse event was due to the competitor replacement fluid (albuprist, india) being outside of quality control guidelines resulting in low levels of electrolytes (namely sodium) and subsequently, a hypotonic environment to the rbc¿s.

• 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: 17343139
• MDR Text Key: 320091236
• Report Number: 1722028-2023-00241
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• 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: 56 YR
• Patient Sex: Male