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

Catalog Number 10220

Device Problems Use of Device Problem (1670); Device Operational Issue (2914)

Patient Problem Hemolysis (1886)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the medical director, the blood bank policy was not followed regarding irradiation.The packed red blood cells (prbcs) were irradiated way too far in advance and placed back into proper storage conditions.The standard blood bank policy states to irradiate the day of dispense, not several units at once that were not ordered.The blood unit used during the event was irradiated on (b)(6) 2017, however, the unit was not used until (b)(6) 2017.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 a pediatric patient was undergoing a therapeutic plasma exchange(tpe) procedure.After processing the first 50 ml of inlet volume, the operator observed hemolysis in the connector of the channel and red-tinged plasma.She disconnected the returnline from the patient and continued the procedure.The 50 ml was diverted into the waste bag to remove the hemolysis.She reconnected the patient and continued the procedure without further issue.The patient successfully completed 2 additional tpe procedures using a freshly irradiated unit.Per the medical director, hemolysis occurred due to an old blood unit that was irradiated on (b)(6) 2017 and it was used during prime.The therapeutic plasma exchange (tpe) set is not available for return.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf confirmed that the spectra optia operated as intended by detecting the reported hemolysis that was observed in the plasma line.Approximately 1.5 minutes into the procedure was the first occurrence of the cells were detected in plasma line from centrifuge alarm.There were 8 more occurrences of this alarm during the first 20 minutes of the procedure.After 20 minutes, the alarms subsided and the procedure continued without any further alarms.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: per the customer, they have successfully performed tpe procedures on this patient using a blood prime without any hemolysis being detected.A photograph was provided by the customer of the connector in the centrifuge filler for investigation.The plasma had a pink tinge above the red blood cell (rbc) layer, which is evidence of hemolysis.The medical director at the customer site suspected that the hemolysis was due to the unit that was used to blood prime the disposable.Review of literature and agency recommendations was performed to evaluate this speculation.The below data supports the statement made by the medical director at the customer site that the hemolysis was due to the unit used to prime the set:according to the article 'irradiated components' by the australian red cross blood service, asde effect of gamma irradiation of red cells is an increase in the level of extracellular potassium.The increase extracellular potassium is an indication that the red cells have lysed.The australian red cross also states that red cells may be irradiated at any time up to 14 days after collection, and thereafter stored for a further 14 days from irradiation.The age of the unit used to prime the set at the time of irradiation is unknown.The unit was used 12 days after irradiation occurred.Additionally, the australian red cross blood service recommends that blood is used within 48 hours of irradiation for pediatric transfusions.According to the article 'irradiation of blood products' published by the royal children's hospital melbourne, the researchers recommends that rbcs and whole blood irradiated more than 14 days after collection should expire either 5 days after irradiation or its original expiry, whichever comes first.Additionally, the royal children's hospital melbourne recommends that in patients where hyperkalaemia is a concern that transfusion occur within 24 hours of irradiation.According to the survey, 'effects of ionizing radiation on blood and blood components' the international atomic energy agency (iaea) compiled a survey of the effects of ionizing radiation on blood and blood components (iaea-tecdoc-934, section 3.5.1, pg 22).Studies have been performed on post-irradiation storage of rbcs, which have concluded that rbcs are damaged during irradiation and data suggests that storage of irradiated red blood cells should be limited.Root cause: based on the clinical findings as reported by the customer and literature review, the hemolysis in the set was from the unit used to prime the set.This unit of blood was irradiated outside of the acceptable timeframe for use per the customer's procedures.Citation:australian red cross blood service.(2017, april 10).Transfusion-associated graft-versus-host disease (ta-gvhd).Retrieved fromhttps://www.Transfusion.Com.Au/adverse_transfusion_reactions/ta-gvhdinternational atomic energy agency.(1997).Effects of ionizing radiation on blood and blood components: a survey (934).Vienna, austria: author.The royal children's hospital melbourne.(n.D.).Irradiation of blood products.Retrieved fromhttp://www.Rch.Org.Au/bloodtrans/about_blood_products/irradiation_of_blood_products/.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6413376
• MDR Text Key: 70553777
• Report Number: 1722028-2017-00085
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2017

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: 01/01/2019
• Device Catalogue Number: 10220
• Device Lot Number: 01A3227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/11/2017; 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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: 00015 MO
• Patient Weight: 12