MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA RBCX SET

Catalog Number 70700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the article, for all rbcx patients, ports are not accessed for routine pretransfusion labs, but may be accessed by emergency department or hematology clinic nurses using huber needles if patients have acute illnesses requiring intravenous fluids or medications.All ports are flushed with 100 units/ml heparin, and recombinant tissue plasminogen activator is instilled if catheters do not flush or draw blood well or if the met or arbcx procedure cannot be completed due to inadequate blood flow.A central venous catheter (cvl) infection was defined as a positive blood culture from the cvl, without another known infectious site.Most children in this cohort had cvls: 13 (35%) had single-lumen ports, 18 (49%) had double-lumen ports, and 6 (16%) had no catheter during the study period.Among patients with cvls, those who had received arbcx had a significantly higher rate of catheter complications, with 15 of 20 arbcx recipients (75%) having a catheter complication compared with 0 of 11 patients who had never received arbcx (p <0.001).Table 3 delineates catheter complications during the study period.Recipients of arbcx had median 2 catheters (iqr 1,2) during the study period, compared with median 1 catheter (iqr 0,1) in met recipients (p < 0.001).None of the 11 patients with a catheter who had never received arbcx developed any catheter complications.There were no complications of peripheral venous access in patients without cvls.The authors cited that the greater catheter complication rate in arbcx patients is not surprising.In the cooperative study of sickle cell disease, 11.3% of participants experienced venous thromboembolism by age 40.12 vessel stenosis and thrombosis are directly related to the duration of catheter use and catheter diameter.The authors speculated that adults with scd might have greater risk factors for catheter-associated thrombosis, such as increased thrombin generation in older patients.Article citation: woods d, hayashi rj, binkley mm, sparks gw, hulbert ml.Increased complications of chronic erythrocytapheresis compared with manual exchange transfusions in children and adolescents with sickle cell disease.Pediatr blood cancer.2017;64:e26635.Https://doi.Org/ 10.1002/pbc.26635 investigation is in process.A follow-up report will be provided.[.

Event Description

Per the article, increased complications of chronic erythrocytapheresis compared with manual exchange transfusions in children and adolescents with sickle cell disease, in the journal pediatric blood & cancer, a comparison study was performed between pediatric patients with sickle cell disease who underwent manual exchange transfusion (met) or red blood cell exchange (rbcx) with cobe spectra.All rbcx patients had double-lumen bard ports ranging from 4.5 french to 10 french, except two patients who had 11- french double-lumen vortex ports placed in 2012.For rbcx, ports are accessed by pheresis nurses using 16- gauge, 3- inch, non coring arrow needles.Rbcx blood volumes were calculated before each transfusion based on the pretransfusion hb and past month¿s hb s concentration, with a post-arbcx goal hb of 10 g/dl.Isovolemic hemodilution was not used.Six rbcx recipients had 11 episodes of central venous catheter (cvl) infections.Of these, two had multiple episodes.Identified organisms were coagulase-negative staphylococcus species, candida albicans, bordetella holmesii, unidentified bacillus species, methicillin-resistant staph aureus, and viridans group streptococcus species.Three patients had cvls removed due to inability to clear the infection with antibiotics; one also had a catheter- associated thrombus.Specific patient details related to the microbial infections were not provided in the article, therefore, this report is being filed as a summary of the microbial infections that occurred.Specific details regarding antibiotics and other treatments for the microbila infections were not provided.Patient information and outcomes are not available at this time.At the beginning of the study period, the patients¿ median age was 11 years (range 2¿21 years).Thirty-four patients (92%) had hb ss disease, two (5%) had hb s-b0 thalassemia and one (3%) had hb s-b+ thalassemia.The disposable sets are not available for return because they were discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h6 & h10.Investigation: according to internal sterility documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

The customer did not respond to attempts to obtain patient information.

Manufacturer Narrative

This report is being filed to provide additional information in g.4, h.6 and h.10.Investigation: this is a single-institution, retrospective cohort study during a 5-year period from 2008 through 2012, the disposable sets were not available for evaluation.Root cause: in this cohort, arbcx recipients received transfusion therapy for a longer period of time, with more catheter days.The double-lumen infusion ports utilized for arbcx have larger catheter diameters than the single-lumen infusion ports used for most patients with met, likely increasing the thrombosis risk.Second, accessing a port for arbcx requires larger diameter needles than formet, resulting in greater stress on the port¿s reservoir and presumably a greater risk for catheter malfunction.The authors cited that the greater catheter complication rate in arbcx patients is not surprising.In the cooperative study of sickle cell disease, 11.3% of participants experienced venous thromboembolism by age 40.Vessel stenosis and thrombosis are directly related to the duration of catheter use and catheter diameter.The authors speculated that adults with scd might have greater risk factors for catheter-associated thrombosis, such as increased thrombin generation in older patients.

Manufacturer Narrative

This report is being filed to provide additional information in e.3 and h.10.Investigation: the customer reported that 6 recipients tested positive for the following bacteria: coagulase- negative staphylococcus species, candida albicans, bordetella holmesii, bacillus species, methicillin-resistant staphylococcus aureus (mrsa) and viridans group streptococcus species.Per literature review, coagulase-negative staphylococci (cns) are differentiated from the closely related but more virulent staphylococcus aureus by their inability to produce free coagulase.Currently, there are over 40 recognized species of cns.These organisms typically reside on healthy human skin and mucus membranes, rarely cause disease, and are most frequently encountered by clinicians as contaminants of microbiological cultures.However, cns have been increasingly recognized to cause clinically significant infections.The conversion of the cns from symbiont to human pathogen has been a direct reflection of the use of indwelling medical devices (source: coagulase-negative staphylococcal infections kathie l.Rogers, phd, paul d.Fey, phd, mark e.Rupp, md.Infect dis clin n am 23 (2009) 73¿98.Per literature review, candida albicans is an emerging multidrug-resistant fungal pathogen representing an important source of invasive disease in humans and generating high healthcare costs worldwide.This fungus is frequently found in different anatomical sites of healthy persons and could induce systemic and superficial infections under optimal environmental conditions.C.Albicans is a member of the human microflora as a diploid polymorphic yeast of mucosal surfaces and is commonly found in the human gastrointestinal (gi), respiratory, and genitourinary tracts.It is generally a harmless commensal fungus that can turn into an opportunistic organism in immunocompromised or immunologically deficient individuals (source: candida albicans - biology, molecular characterization, pathogenicity, and advances in diagnosis and control ¿ an update maryam dadara, ruchi tiwarib, kumaragurubaran karthikc, sandip chakrabortyd, youcef shahalia, kuldeep dhama.Microbial pathogenesis 117 (2018) 128¿138.Per literature review, bordetella holmesii, a gram-negative bacterium was first described as a cause of bacteraemia in patients with comorbidities such as asplenia.The bacterium was also recovered in nasopharyngeal samples in otherwise healthy individuals with pertussis-like symptoms.It is believed to cause both invasive infections (bacteraemia, meningitis, endocarditis, pericarditis, pneumonia, and arthritis) and pertussis-like symptoms.Infection with b holmesii is frequently misidentified as being with b pertussis, the cause of whooping cough, because routine diagnostic tests for pertussis are not species-specific (source: bordetella holmesii: an under-recognised bordetella species laure f pittet, stéphane emonet, jacques schrenzel, claire-anne siegrist, klara m posfay-barbe.Lancet infect dis 2014; 14: 510¿19.Per literature review, bacillus organisms are widely distributed in the environment although the primary habitat is the soil.These organisms are usually found in decaying organic matter, dust, vegetable, water, and some species are part of the normal flora.In the clinical setting, outbreaks and pseudo epidemic have been traced to contaminated ventilator equipment, disinfectant (ethyl alcohol), hospital linen and dialysis equipment (source: bacillus species carmelita u.Tuazon, m.D., m.P.H.Infectious disease and antimicrobial therapy.Per literature review, mrsa is able to persist not only in hospitals (with a high level of antimicrobial agent use) but also in the community (with a low level of antimicrobial agent use).Staphylococcus aureus colonizes the nasal mucosa of approximately 30% of individuals.It is associated with a wide range of infections including skin and soft tissue infections (sstis, such as bullous impetigo, abscesses, furunculosis, and staphylococcal scalded skin syndrome), systemic or fatal infections [such as blood stream infection(bsi), endocarditis, and pneumonia], and toxin-associated diseases (such as toxic shock syndrome and food poisoning) (source: community-acquired methicillin-resistant staphylococcus aureus: community transmission, pathogenesis, and drug resistance tatsuo yamamoto, akihito nishiyama, tomomi takano, shizuka yabe, wataru higuchi, olga razvina, da shisee.J infect chemother (2010) 16:225¿254.Per literature review, the viridans group streptococci (vgs) are a heterogeneous group of organisms which exist as commensals in the oropharynx and the gut.They cause serious infections when they gain entry into sterile sites particularly in patients with predisposing conditions.All vgs are catalase-negative, gram-positive cocci in chains which are leucine aminopeptidase positive, pyrrolidonylarylamidase negative and do not grow in bile esculin agar or 6.5% nacl (source: understanding the viridians group streptococci: are we there yet? t menon.Indian journal of medical microbiology, (2016) 34(4): 421-426.Based on the investigation results and the sterility assurance system employed at terumo bct, the disposable set or system is not the source of the bacterial contamination.Investigation is in process.A follow up report will be provided.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA RBCX SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9924645
• MDR Text Key: 197305747
• Report Number: 1722028-2020-00150
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 03/04/2021; 03/31/2021; 04/29/2021
• Supplement Dates FDA Received: 03/24/2021; 04/16/2021; 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other