MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLT,SAMPLER,AUTOPAS,PLASMA,RBC SET

Catalog Number 82420

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.

Event Description

The customer reported that a donor had a suspected ethylene oxide (eto) reaction during acytapheresis procedure.Per the customer, the donor developed an 'allergic-type' shock and was transferred to the emergency room (er).The er physician noticed that the donor developed inflammation in the face, therefore, the donor was given 25mg of solu-medroll, 5 mg of xyzal, 0.25mg of xanax, and 5mg of am br viaiv.The patient was monitored for 6 hours and the patient was asymptomatic.Due to eu personal data protection laws, the patient identifier and weight are not available from the customer.The trima cytapheresis set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

Patient's weight was obtained from the run data file (rdf).

Manufacturer Narrative

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.

Manufacturer Narrative

According to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.During customer follow-up, the customer stated that the anaphylactic reaction was confirmed by high tryptase levels and the donor was released from the er with the recommendation to see an allergist.The run data file (rdf) was analyzed for this event.Review of the rdf showed that the platelet valve opened at 12.9 minutes.The operator lowered the ac adjustment meter at 23.5 minutes into the procedure.The total amount of ac reported by the trima accel device was 157 ml with 92 mls to the donor, 6 mls in the platelet product, 45 mls in the plasma product and the remaining 14 mls in the disposable set.There were no events (alerts, adjustments, changes in pump speed, etc.) during the run that could have caused an ac reaction.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: preventative maintenance (pm) checks were performed on the machine in 03/2017 and 09/2017.The pms were completed per manufacture's guidelines and no issues were found.Root cause: a definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.Review of the run data file (rdf) showed that the platelet valve opened at 12.9 minutes.The operator lowered the ac adjustment meter at 23.5 minutes into the procedure.The total amount of ac reported by the trima accel device was 157 ml with 92mls to the donor, 6mls in the platelet product, 45mls in the plasma product and the remaining 14mls in the disposable set.There were no events (alerts, adjustments, changes in pump speed, etc.) during the run that could have caused an ac reaction.

Manufacturer Narrative

Updated root cause: a definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.Review of the run data file showed that the platelet valve opened at 12.9 minutes.The operator lowered the ac adjustment meter at 23.5 minutes into the procedure.The total amount of ac reported by the trima accel device was 157 ml with 92mls to the donor, 6mls in the platelet product, 45mls in the plasma product and the remaining 14mls in the kit.The review of the procedure record confirmed that the trima accel system operated as intended.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLT,SAMPLER,AUTOPAS,PLASMA,RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7108690
• MDR Text Key: 94541417
• Report Number: 1722028-2017-00480
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 82420
• Device Lot Number: 08Z1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2016
• 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: 00059 YR
• Patient Weight: 84