MAUDE Adverse Event Report: TERUMO BCT COBE 2991; COBE 2991 BLOOD CELL PROCESSING SET

Catalog Number	90819
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported a microbial contamination in a blood marrow product after a collection on a cobe device.Per the customer, the stem cell culture was positive for gram +ve cocci.The product was infused to a patient.The patient is reported to be "clinically stable" and afebrile.Patient age and weight are not available at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a.2, a.4 and b.5 and corrected information in d.2b.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported a microbial contamination in a blood marrow product after a collection on a cobe device.Per the customer, the stem cell culture was positive for gram +ve cocci.The product was infused to a patient.The patient is reported to be "clinically stable" and afebrile.Full donor id: nmdp donor grid# (b)(6).The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported a microbial contamination in a blood marrow product after a collection on a cobe device.Per the customer, the stem cell culture was positive for gram +ve cocci.The product was infused to a patient.The patient is reported to be "clinically stable" and afebrile.Full donor id: (b)(6) the collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a literature review was conducted for the organisms identified by the customer.Staphylococcus capitis is a member of cons (coagulase-negative staphylococci) and was first identified by kloos and schleifer in 1975.S.Capitis has two subspecies and acts as normal flora of human ears, neck, face and scalp.This bacterium comprises 5% of all cons bacteria and has the ability to induce numerous severe infections such as otitis externa, infective endocarditis (prosthetic and native valve endocarditis), cellulitis, primary chronic osteomyelitis, urinary tract infection, late- and early-onset sepsis, orthopaedic periprosthetic infections, pneumonia and catheter-associated bloodstream infections.Patients with a suppressed immune system or underlying cardiac disease are considered to be highly susceptible to these infections, so they are therefore categorized into the high-risk groups.S.Capitis is generally reported in premature neonates and is occasionally identified in neonatal intensive care unit outbreaks.(t.Azimi et al., 2020).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.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found zero (0) other reports for similar issues (microbial contamination) on this lot investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported a microbial contamination in a blood marrow product after a collection on a cobe device.Per the customer, the stem cell culture was positive for gram +ve cocci.The product was infused to a patient.The patient is reported to be "clinically stable" and afebrile.Full donor id: nmdp donor grid# (b)(6) the collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported a microbial contamination in a blood marrow product after a collection on a cobe device.Per the customer, the stem cell culture was positive for gram +ve cocci.The product was infused to a patient.The patient is reported to be "clinically stable" and afebrile.Full donor id: nmdp donor grid# (b)(4) the collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a literature review was conducted for the organisms identified by the customer.Staphylococcus capitis is a member of cons (coagulase-negative staphylococci) and was first identified by kloos and schleifer in 1975.S.Capitis has two subspecies and acts as normal flora of human ears, neck, face and scalp.This bacterium comprises 5% of all cons bacteria and has the ability to induce numerous severe infections such as otitis externa, infective endocarditis (prosthetic and native valve endocarditis), cellulitis, primary chronic osteomyelitis, urinary tract infection, late- and early-onset sepsis, orthopaedic periprosthetic infections, pneumonia and catheter-associated bloodstream infections.Patients with a suppressed immune system or underlying cardiac disease are considered to be highly susceptible to these infections, so they are therefore categorized into the high-risk groups.S.Capitis is generally reported in premature neonates and is occasionally identified in neonatal intensive care unit outbreaks.(t.Azimi et al., 2020).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.Per and internal 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 a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found zero (0) other reports for similar issues (microbial contamination) on this lot 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 but it is likely due to one or a combination of the possible causes listed below: * patients' underlying disease diagnosis (immunocompromised host) and/or the species was endogenous and originated from the patient.* disposable set was improperly handled * disposable set was improperly stored * disposable set leak e.G.Via seizure of the ceramic seal.

• Brand Name: COBE 2991
• Common Device Name: COBE 2991 BLOOD CELL PROCESSING 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: 20482703
• Report Number: 1722028-2024-00444
• Device Sequence Number: 3614945
• Product Code: GKT
• UDI-Device Identifier: 05020583908192
• UDI-Public: 05020583908192
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: BK080035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Catalogue Number: 90819
• Device Lot Number: 04H15001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 01/29/2025; 03/10/2025; 03/14/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/21/2025; 02/13/2025; 03/10/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 79 KG