MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET,PLASMA, RBC AUTO PAS SET

Catalog Number 80410

Device Problem Patient-Device Incompatibility (2682)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Chills (2191); Reaction (2414)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this double plateletpheresis collection.Review of the rdf indicated the targeted double platelet and plasma collection on the trimaaccel system were collected successfully without incident.The targeted platelet additive solution(pas) volume was added successfully to the platelet product post-collection.There was no indication of events during the product collection or pas addition that could have caused the product to be compromised.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient developed chills, fever, increased blood pressure, and tachycardia during a platelet transfusion procedure.Blood cultures from the patient and the empty platelet bag grew klebsiella pneumaniae.A second platelet concentrate from the same collection was transfused to a different patient without patient reaction, however the patient had been on antibiotics due to his illness.A blood culture was done of the empty bag of this platelet concentrate and showed no bacteria.Plasma was also collected concurrently with the platelet concentrates.A blood culture showed no bacteria in the plasma.Donation and preparation protocols were checked by the customer and were normal.The donor was not ill after the donation.Per the customer, the platelet concentrate came from a double plateletpheresis from (b)(6) 2015.The time between donation and pathogen inactivation was 6 hours.Due to eu personal data protection laws, the patient identifier is not available from the customer.The disposable set is not available for return, because the customer discarded it.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: per literature review, klebsiella pneumoniae is a type of gram-negative bacteria that can cause different types of health-care associated infections.In health care settings, the bacteria can be spread from patient to patient via contaminated hands of health care personnel or exposure through catheters.Klebsiella bacteria are normally found in the human intestines (where they do not cause disease).They are also found in human stool (feces).Per terumo bct's internal quality labs report, the phenomenon of bacterial contamination in blood products is known to occur.Given the nature of microorganisms on human skin and the mechanical act of piercing the skin, it is not possible to completely eliminate bacterial contamination from occurring the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

Follow up discussion with the physician shows that the patient received 40mg solumedrol and 2mg tavegyl in response to the reaction.The next day they started with antibiotic therapy with rocephin after confirmation of the positive blood culture.This therapy continued throughout his stay at the hospital.

Manufacturer Narrative

Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.Follow up information from the physician is that the most likely cause is a mild infection from the donor.Between collection and pathogen inactivation, the germ count then grew to a number that was in the "grey zone" of cerus' pi capacity.This explains why the pi could have been successful in one platelet product but not successful in the other bag.Root cause: according to physician statements, the cause for the bacterial infection and transfusion reaction is from a mild infection from the donor.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET,PLASMA, RBC AUTO PAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5353697
• MDR Text Key: 35358369
• Report Number: 1722028-2016-00006
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK150269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: 80410
• Device Lot Number: 06Y1117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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
• Patient Age: 00089 YR
• Patient Weight: 100