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

Model Number 12120

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer tested a set from the same box and it came back negative for any growth.The child had 5 days of antibiotics and was collected again with no growth in the product bag.One theory, per the customer, is that the child had a small blood level of ecoli that did not grow on culture, however when cells were collected in a small concentrated level (5ml per bottle) the e.Coli was detected.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they collected mononuclear cell (mnc) products on a patient three separate times, and all three products tested positive for e.Coli.All three products were collected from kits that were in the same box.The first two collections were done on the patient using a femoral line.The femoral line was removed and a jugular line was placed for the third collection.The femoral line tip was not tested when it was removed.Per the customer, there was nothing unusual about the procedure.This report is being filed for the first of three procedures.The patient was put on meropenem on the second day collection.Patient identifier is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

The customer declined to provide the patient identifier.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6, and h.10.Investigation: a disposables complaint history search for lot 2003193130 and found no other reports of bacterial contamination.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer tested a set from the box that staff had been using (same lot number) and results came back negative for any growth.Femoral vein catheters are more likely to become infected than subclavian or internal jugular vein catheters, and multilumen catheters may also have a higher rate of infection than single lumen catheters, but this may not be clinically significant since multilumen catheters are typically used for short periods of time.Source: bullard km, dunn dl.Bloodstream and intravascular catheter infections.In: holzheimer rg, mannick ja, editors.Surgical treatment: evidence-based and problem-oriented.Munich: zuckschwerdt; 2001.Available from: https://www.Ncbi.Nlm.Nih.Gov/books/nbk7008/.Per 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.Corrected information is provided in h.10.Investigation: per literature review: escherichia coli is a gram-negative bacterium and is the most numerous aerobic commensal inhabitant of the large intestine.Certain strains cause diarrhea and all can cause infection when they invade sterile sites.Infection of the bloodstream remains a life-threatening occurrence and is most commonly associated with the presence of a central vascular catheter, but may also be associated with a gram-negative infection in other areas of the body, such as the lung, genitourinary tract, or abdomen.Approximately 30% of hospital-acquired bloodstream infections in icus in the united states are due to gram-negative organisms, although this proportion is lower when hospital-wide data are examined.Given an adequate portal of entry, almost any gram-negative organism can cause bloodstream infection; however, the most common organisms include klebsiella species, escherichia coli, enterobacter species, and p.Aeruginosa.[a.Y.Peleg et al.Hospital-acquired infections due to gram-negative bacteria.N engl j med.2010 may 13; 362(19): 1804¿1813.] according to the cdc 'guidelines for the prevention of intravascular catheter-related infections (2011)': in the united states, 15 million central vascular catheter (cvc) days (i.E., the total number of days of exposure to cvcs among all patients in the selected population during the selected time period) occur in intensive care units (icus) each year.Studies have variously addressed catheter related bloodstream infections (crbsi).These infections independently increase hospital costs and length of stay, but have not generally been shown to independently increase mortality.While 80,000 crbsis occur in icus each year, a total of 250,000 cases of bsis have been estimated to occur annually, if entire hospitals are assessed.Root cause: a definitive root cause for the contaminated car t cell products could not be determined.It's possible the patient had a low level catheter related blood stream infection (crbsi) or a non-catheter related infection in another part of the body.Corrected investigation: "femoral vein catheters are more likely to become infected than subclavian or internal jugular vein catheters, and multilumen catheters may also have a higher rate of infection than single lumen catheters, but this may not be clinically significant since multilumen catheters are typically used for short periods of time." provided in supplement 1, is no longer applicable to this investigation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11485299
• MDR Text Key: 241930485
• Report Number: 1722028-2021-00108
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2021

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: 03/01/2022
• Device Model Number: 12120
• Device Catalogue Number: 12120
• Device Lot Number: 2003193130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 04/05/2021; 04/07/2021
• Supplement Dates FDA Received: 04/06/2021; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00007 YR
• Patient Weight: 25