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

Model Number 12320

Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacture and expiry date are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a lymphopheresis collection was done on a patient that was totally asymptomatic and with no records on previous infections and negative autologous pre-donation serologies.A sterility culture performed to lymphocyte collected product resulted positive for serratia marcescens.Sample taken in a class ii safety biologic cabinet from tubing segment detached from mother collection bag (no other samples taken during or after procedure), closed system maintained all the time.Upon positive culture, and approximately 24 hours after collection, cvc (central venous catheter) was removed and samples were taken from patient for culture, resulting all negative.Patient identifier and outcome are unknown at this time.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer provided a microbiology test report to aid in the investigation.The report confirmed that the bacteria identified was serratia marcescens.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer indicated that the sample was taken in a class ii biosafety cabinet from the tubing segment detached from the collection bag.There were no other samples taken during or after the procedure, and a closed system was maintained at all time.The bacterial testing was performed using bruker daltonik maldi biotyper.Per literature review, serratia marcescens is a gram-negative bacillus that produces a red pigment at room temperature.Serratia are considered to be ubiquitous in the environment and the organism is found in water, soil, plants, insects, animals, mammals including humans and food, particularly those rich in starch.There is no evidence to suggest a malfunction of the disposable kit or the spectra optia device caused or contributed to the bacterial contamination.Based on the available information, a specific root cause for the reported bacterial contamination could not be determined.The product was terminally sterilized to a sterility assurance level (sal) of

Event Description

The customer reported that a lymphopheresis collection was done on a patient that was totally asymptomatic and with no records on previous infections and negative autologous pre-donation serologies.A sterility culture performed to lymphocyte collected product resulted positive for serratia marcescens.Sample taken in a class ii safety biologic cabinet from tubing segment detached from mother collection bag (no other samples taken during or after procedure), closed system maintained all the time.Positive bacterial contamination was detected 24 hours after collection and at that moment the patient was administered empiric antibiotics treatment and the patient¿s central venous catheter was removed.Cultures were taken from the patient for bacterial culture and all the results were negative.Patient identifier and outcome are unknown at this time.Terumo bct is awaiting return of the disposable set for evaluation.

Event Description

The customer reported that a lymphopheresis collection was done on a patient that was totally asymptomatic and with no records on previous infections and negative autologous pre-donation serologies.A sterility culture performed to lymphocyte collected product resulted positive for serratia marcescens.Sample taken in a class ii safety biologic cabinet from tubing segment detached from mother collection bag (no other samples taken during or after procedure), closed system maintained all the time.Positive bacterial contamination was detected 24 hours after collection and at that moment the patient was administered empiric antibiotics treatment and the patient¿s central venous catheter was removed.Cultures were taken from the patient for bacterial culture and all the results were negative.Patient identifier and outcome are unknown at this time.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, d.3, h.4, h.6 and h.10.Investigation: the customer provided a microbiology test report to aid in the investigation.The report confirmed that the bacteria identified was serratia marcescens.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer indicated that the sample was taken in a class ii biosafety cabinet from the tubing segment detached from the collection bag.There were no other samples taken during or after the procedure, and a closed system was maintained at all time.The bacterial testing was performed using bruker daltonik maldi biotyper.Per literature review, serratia marcescens is a gram-negative bacillus that produces a red pigment at room temperature.Serratia are considered to be ubiquitous in the environment and the organism is found in water, soil, plants, insects, animals, mammals including humans and food, particularly those rich in starch.There is no evidence to suggest a malfunction of the disposable kit or the spectra optia device caused or contributed to the bacterial contamination.Based on the available information, a specific root cause for the reported bacterial contamination could not be determined.The product was terminally sterilized to a sterility assurance level (sal) of

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL 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: 13142584
• MDR Text Key: 287672425
• Report Number: 1722028-2022-00002
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2015133330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2021
• 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
• Treatment: ACD-A; ACD-A; ACD-A
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 69 KG