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

Catalog Number 70700

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Thrombosis (2100); Stenosis (2263); Reaction (2414)

Event Date 11/28/2016

Event Type  Injury  

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.Thrombosis was defined as a clot that partially or totally occluded the cvl or an adjacent blood vessel, requiring anticoagulation and/or line removal.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 goalhbof 10 g/dl.Isovolemic hemodilution was not used.Some patients who underwent rbcx procedures experienced reactions during the procedures.Five patients developed thrombosis requiring anticoagulation and/or catheter removal: 1 patient had superior vena cava (svc) syndrome with facial swelling.The patient had resolution of the clot with low molecular weight heparin for 6 months.1 patient had thrombophlebitis after the right internal jugular vein was ligated for catheter placement, without thrombosis of the catheter itself.The patient had resolution of the clot with low molecular weight heparin for 6 months.3 were discovered because blood could not be aspirated from the catheter, and the patients underwent catheter removal.Four patients had venous stenosis related to catheters: 1 for the same patient who had superior vena cava (svc) syndrome with facial swelling.The patient later had venous stenosis and had to have the catheter removed.1 patient had svc syndrome without thrombosis; he underwent balloon dilatation with symptom resolution, but facial swelling recurred 4 months later prompting catheter removal.2 patients had stenosis of their subclavian and jugular veins, preventing placement of new double-lumen catheters.All four of these patients switched to met due inadequate venous access for arbcx.Specific patient details related to the patient reactions were not provided in the article, therefore, this report is being filed as a summary of the patient reactions that occurred.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 sb-0 thalassemia and one (3%) had hb sb+ thalassemia.The disposable sets are not available for return because they were discarded by the customer.

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 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

Manufacturer Narrative

This report is being filed to provide additional information in 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.1.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: 9921060
• MDR Text Key: 190155403
• Report Number: 1722028-2020-00149
• 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; Required Intervention