MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMALRS PLATELET PLASMA RBC AUTOPAS SET

Model Number 82410

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

Patient Problem Bacterial Infection (1735)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that three patients who had received platelets by apheresis developed e-coli, aggravating the clinical situation.Two of the patients had to be referred to intensive care.In addition, he reports that a unit of plasma was collected from the same procedure, that it was transfused and that the patient who received it had no problems.Acd a batch 21063039 and pas solution batch 213600054 were used.Patient information is not available at this time.This report is being filed for patient 1.The apheresis set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that three patients who had received platelets by apheresis developed e-coli, aggravating the clinical situation.Two of the patients had to be referred to intensive care.In addition, he reports that a unit of plasma was collected from the same procedure, that it was transfused and that the patient who received it had no problems.Acd a batch 21063039 and pas solution batch 213600054 were used.Patient information is not available at this time.This report is being filed for patient 1.The apheresis set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A literature review was conducted for the organisms identified by the customer.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 diarrhoea 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.(peleg & hooper, 2010) there are 0.2-micron filters on both the acda and saline lines so the likelihood of introducing bacteria through these two routes are unlikely.A batch document review of acda lot and the t-pas lot provided by the customer identified no other related complaints, no allegations of potential contamination and all lots manufactured passed all in-house quality testing and went through the steam sterilization process.Per the 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.Peleg, a.Y., & hooper, d.C.(2010).Hospital-acquired infections due to gram-negative bacteria.New england journal of medicine, 362(19), 1804¿1813.Https://doi.Org/10.1056/nejmra0904124 investigation is in process.A follow up report will be provided.

Event Description

The customer reported that three patients who had received platelets by apheresis developed e-coli, aggravating the clinical situation.Two of the patients had to be referred to intensive care.In addition, he reports that a unit of plasma was collected from the same procedure, that it was transfused and that the patient who received it had no problems.Acd a batch 21063039 and pas solution batch 213600054 were used.Patient information is not available at this time.This report is being filed for patient 1.The apheresis set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found zero reports for similar issues on this lot.A literature review was conducted for the organisms identified by the customer.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 diarrhoea 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.(peleg & hooper, 2010) there are 0.2-micron filters on both the acda and saline lines so the likelihood of introducing bacteria through these two routes are unlikely.A batch document review of acda lot and the t-pas lot provided by the customer identified no other related complaints, no allegations of potential contamination and all lots manufactured passed all in-house quality testing and went through the steam sterilization process.Per the 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.Peleg, a.Y., & hooper, d.C.(2010).Hospital-acquired infections due to gram-negative bacteria.New england journal of medicine, 362(19), 1804¿1813.Https://doi.Org/10.1056/nejmra0904124 root cause: a root cause assessment was performed for the microbial contamination.A definitive root cause for the contaminated platelet products could not be determined.It's possible the donor had a low-level catheter related blood stream infection (crbsi) or a non-catheter related infection in another part of the body.It is unknown if the transfused plasma product which had no reaction was pre-treated using mirasol but it is likely that the bacteria was neutralized by the nature of the complement system in the plasma thus the plasma product was negative.Based on the information provides, potential root causes include, but are not limited to: *patients' underlying disease diagnosis (immunocompromised host) and/or the species was endogenous and originated from the patient.*poor venipuncture technique and/or no blood diversion leads to bacteria introduced at access site resulting in product contamination.

Event Description

The customer reported that three patients who had received platelets by apheresis developed e-coli, aggravating the clinical situation.Two of the patients had to be referred to intensive care.In addition, he reports that a unit of plasma was collected from the same procedure, that it was transfused and that the patient who received it had no problems.Acd a batch 21063039 and pas solution batch 213600054 were used.Patient information is not available at this time.This report is being filed for patient 1.The apheresis set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMALRS PLATELET PLASMA RBC AUTOPAS 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: 16479306
• MDR Text Key: 310704188
• Report Number: 1722028-2023-00091
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Model Number: 82410
• Device Catalogue Number: 82410
• Device Lot Number: 2204113330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2022
• 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
• Patient Outcome(s): Other