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

Catalog Number 80420

Device Problem Contamination (1120)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Chills (2191); Reaction (2414); Fungal Infection (2419)

Event Date 02/07/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer will perform blood culturing in their facility and on devices, such as the agitator.In ethylene oxide (eto) sterilization, the endospore, which can only be formed by specific types of bacteria, has been demonstrated to be the most resistant life form in regards to having the potential to survive eto sterilization.The eto sterilization process employed at terumo bct used to sterilize terumo bct devices has been validated using bacterial endospores of bacillus atrophaeus.The endospores of bacillus atrophaeus are recognized by industry to be the most resistant to eto sterilization.The terumo bct sterilization cycle has been validated using the conservative over-kill approach which means the cycle is capable of delivering a 12 log reduction to a population of organisms with the resistance equivalent to that of bacillus atrophaeus endospores.For organisms that are not as resistant as bacillus atrophaeus endospores, the process would deliver an even greater log reduction.Fungi (mold) organisms are not capable of forming endospores.Therefore they are not as resistant to eto sterilization as bacillus atrophaeus endospores.Consequently it maybe concluded that the sterilization cycle used to sterilize trima at terumo bct has the ability to kfungal organisms if present during the cycle.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a (b)(6) test result for mold fungi from the blood culture of a platelet concentrate product.The donation of the platelet concentrate was conducted on (b)(6) 2016 and produced 2 platelet units and 1 plasma unit.Both platelet units were blood cultured at the time and came back (b)(6).Platelet unit 1 was transfused to a multi-transfused patient with no adverse reactions.Platelet unit 2 was transfused on (b)(6) 2016 to another patient who was concurrently transfused with a red blood cell unit.The patient receiving unit 2 had a reaction, with a high fever (39.5 degrees c), chills and increased blood pressure and pulse.A blood culture done of the red blood cell unit came back (b)(6) and platelet unit 2 showed growth of mold fungi.Per the customer, the frozen plasma unit that was collected with the platelets has been sent for blood culturing.Due to (b)(6) personal data protection laws, the patient information is not available from the customer.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer performed internal analysis on the platelet product, which tested positive for penicillium species.Penicillium is normally associated with customer facility site conditions.The run data file was analyzed for this event.Root cause: review of the run data file showed a successful platelet and plasma collection with no remarkable events during the procedure.Signals showed that platelets were collected as expected, the platelet concentration was consistent throughout the collection and donor rinse back was performed successfully.There was no indication of events during the product collection that could have caused the product to be compromised.As provided in the investigation details, it may be concluded that the sterilization cycle used to sterilize trima at terumo bct in (b)(4) has the ability to kill fungal organisms if present during the sterilization cycle.Based on the results of the detailed investigation, it is concluded that there is no direct implication between the trima product and the alleged contamination.It is possible the presence of bacteria was the result of product handling or phlebotomist activities.

Event Description

The patient's gender and weight were obtained from the run data file (rdf).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, AUTOPAS RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5496101
• MDR Text Key: 40204898
• Report Number: 1722028-2016-00124
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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
• Report Date: 03/11/2016

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 Expiration Date: 12/01/2017
• Device Catalogue Number: 80420
• Device Lot Number: 12Y1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• 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 Weight: 94