MAUDE Adverse Event Report: TERUMOBCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET

Model Number 12320

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

Patient Problem Bacterial Infection (1735)

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported after the completion of the cmnc cell collection, they determined via pbsc preparation that a contamination occurred.The contamination has been identified in both the procurement and transplantation facilities.The designation staphylococcus aureus has been defined.The plasma microbiological test result was negative.Per the customer the product was transfused.The status of the patient is listed in good condition and medical intervention was provided in the form of antibiotics.Due to eu personal data protection laws, further patient information is not available from the customer.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported after the completion of the cmnc cell collection, they determined via pbsc preparation that a contamination occurred.The contamination has been identified in both the procurement and transplantation facilities.The designation staphylococcus aureus has been defined.The plasma microbiological test result was negative.Per the customer the product was transfused.The status of the patient is listed in good condition and medical intervention was provided in the form of antibiotics.Due to eu personal data protection laws, further patient information is not available from the customer.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no other reports for similar issues reported on this lot.A pbsc collection was performed on a patient on the 16th of march 2023.The product was the cultured using the pbsc product and plasma bag and staphylococcus aureus was identified in the collection bag while the plasma bag remained negative.The product was not treated with mirasol.The recipient presented with acute lymphoblastic leukemia (all) and was reported to be in good condition after receiving medical intervention.The medical intervention provided is unknown.The customer reported that the patient ¿ recipient was located in a different hospital as to where the procedure took place and therefore cannot be provided.A literature review was conducted for the organism identified by the customer.Per literature review, staphylococcus aureus is a major bacterial human pathogen that causes a wide variety of clinical manifestations.Staphylococcus aureus is a gram-positive bacteria that can cause a wide variety of clinical diseases.Infections caused by this pathogen are common both in community-acquired and hospital-acquired settings.(park and seo, 2022) s.Aureus is found in the environment and is also found in normal human flora, located on the skin and mucous membranes (most often the nasal area) of most healthy individuals.S.Aureus does not normally cause infection on healthy skin; however, if it is allowed to enter the bloodstream or internal tissues, these bacteria may cause a variety of potentially serious infections.Transmission is typically from direct contact by touching infected blood or body fluids, most often by contaminated hands.Certain groups of people are more at risk than others to develop a serious s.Aureus infection; this includes people with conditions such as: diabetes, cancer, vascular disease, patients who are hospitalized in intensive care units (icus), patients who have undergone certain types of surgeries, and patients with medical devices inserted in their bodies, such as central lines and catheters.(park and seo, 2022; ¿staphylococcus aureus - apic,¿ n.D.) staphylococcus aureus is gram-positive bacteria (stain purple by gram stain) that are cocci-shaped and tend to be arranged in clusters that are described as ¿grape-like.¿ on media, these organisms can grow in up to 10% salt, and colonies are often golden or yellow (aureus means golden or yellow).These organisms can grow aerobically or anaerobically (facultative) and at temperatures between 18 c and 40 c.(park and seo, 2022) per technical report, the phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.Park, j.Y., seo, k.S., 2022.Food microbiology: fundamentals and frontiers 555¿584.Staphylococcus aureus - apic [www document], n.D.Url https://apic.Org/monthly_alerts/staphylococcus-aureus/ (accessed 5.18.23).Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no other reports for similar issues reported on this lot.A pbsc collection was performed on a patient on the (b)(6) 2023.The product was the cultured using the pbsc product and plasma bag and staphylococcus aureus was identified in the collection bag while the plasma bag remained negative.The product was not treated with mirasol.The recipient presented with acute lymphoblastic leukemia (all) and was reported to be in good condition after receiving medical intervention.The medical intervention provided is unknown.The customer reported that the patient ¿ recipient was located in a different hospital as to where the procedure took place and therefore cannot be provided.A literature review was conducted for the organism identified by the customer.Per literature review, staphylococcus aureus is a major bacterial human pathogen that causes a wide variety of clinical manifestations.Staphylococcus aureus is a gram-positive bacteria that can cause a wide variety of clinical diseases.Infections caused by this pathogen are common both in community-acquired and hospital-acquired settings.(park and seo, 2022) s.Aureus is found in the environment and is also found in normal human flora, located on the skin and mucous membranes (most often the nasal area) of most healthy individuals.S.Aureus does not normally cause infection on healthy skin; however, if it is allowed to enter the bloodstream or internal tissues, these bacteria may cause a variety of potentially serious infections.Transmission is typically from direct contact by touching infected blood or body fluids, most often by contaminated hands.Certain groups of people are more at risk than others to develop a serious s.Aureus infection; this includes people with conditions such as: diabetes, cancer, vascular disease, patients who are hospitalized in intensive care units (icus), patients who have undergone certain types of surgeries, and patients with medical devices inserted in their bodies, such as central lines and catheters.(park and seo, 2022; ¿staphylococcus aureus - apic,¿ n.D.) staphylococcus aureus is gram-positive bacteria (stain purple by gram stain) that are cocci-shaped and tend to be arranged in clusters that are described as ¿grape-like.¿ on media, these organisms can grow in up to 10% salt, and colonies are often golden or yellow (aureus means golden or yellow).These organisms can grow aerobically or anaerobically (facultative) and at temperatures between 18 c and 40 c.(park and seo, 2022) per technical report, the phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.Park, j.Y., seo, k.S., 2022.Food microbiology: fundamentals and frontiers 555¿584.Staphylococcus aureus - apic [www document], n.D.Url https://apic.Org/monthly_alerts/staphylococcus-aureus/ (accessed 5.18.23).Root cause: a root cause assessment was performed for the microbial contamination.Based on the available information a definitive root cause could not be determined.S.Aureus is a ubiquitous skin flora, it is therefore likely that the contaminated skin plug from the donor passed through the inlet line filter and ended up in the idl channel for collection along with the stem cells.Due to the nature of the complement system in the plasma, these were then neutralized resulting in a negative plasma product.Therefore, the likely root causes include but are not limited to: * improper venipuncture technique introduces bacteria at access site resulting in bacterial growth in product bag.* bacteria on skin surface causing the skin plug to contaminate the disposable set resulting in the bacterial contamination of product.* in place catheter used for collection led to bacteria being introduced at the access site resulting in product contamination.* the post procedure processing of the collected product was not performed aseptically resulting in product contamination.

Event Description

The customer reported after the completion of the cmnc cell collection, they determined via pbsc preparation that a contamination occurred.The contamination has been identified in both the procurement and transplantation facilities.The designation staphylococcus aureus has been defined.The plasma microbiological test result was negative.Per the customer the product was transfused.The status of the patient is listed in good condition and medical intervention was provided in the form of antibiotics.Due to eu personal data protection laws, further patient information is not available from the customer.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMOBCT; 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: 16786624
• MDR Text Key: 313739648
• Report Number: 1722028-2023-00148
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

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 Model Number: 12320
• Device Catalogue Number: 4123201
• Device Lot Number: 2301046141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/18/2023; 08/30/2023
• Supplement Dates FDA Received: 06/09/2023; 09/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2022
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 90 KG