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

Catalog Number 000000000000080301

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144); Tingling (2171); Complaint, Ill-Defined (2331)

Event Date 05/19/2014

Event Type  Injury  

Event Description

The customer reported that a donor had a 'severe reaction' at the end of the donation procedure.Approximately, 76 minutes into the donation, the donor complained that he felt tingling, hot, nauseated, then vomited.The donor recovered briefly and did not experience loss of consciousness, but the reaction progressed and the donor developed a cough which exacerbated his asthma and felt a tightness in his chest.An ambulance was called for the donor.Full patient id: (b)(6) patient's (donor's) age/date of birth is not available due to eu privacy protection laws.The customer chose to provide other patient information.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to medical intervention in the form of an ambulance being called for donor reaction.

Manufacturer Narrative

Investigation: per the customer, it was the donors 37th donation, all of which have been fairly uneventful other than some slight tingling during those donations which had been managed by reducing the anticoagulant (ac).The donor did not mention suffering from a tingling sensation during this donation, but after the donation had been stopped, he did mention that he had experienced some tingling towards the end of the procedure but did not tell staff members as he"did not want to make a fuss".The rdf was analyzed for this event.The run data file analysis did not show a root cause for the donor¿s adverse reaction.However, it is possible that the ¿return pressure high¿ alert that was generated during rinseback may have caused the donor to have a vasovagal response.Investigation is in process.A follow-up report will be provided.

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 review of the lot for similar reports was carried out, none have been reported.A service call was placed for the machine.The service call was completed and all tests passed without any issues.The customer stated that in response to the donor's reaction, the donor was tipped back in the chair, legs raised and a fan was used to cool him down.The terumo bct trima clinical specialist was consulted.Per the clinical specialist, the reaction appeared to not be a citrate reaction, but a vasovagal response.This response could have been caused by donor dehydration, the return pressure high alert during rinseback as seen in the rdf,or a combination of the two.She also mentioned that tingling that occurs at the end of the procedure will not cause a citrate reaction because the donor has already metabolized the citrate by that point.Root cause: this disposable set was unavailable for specific root cause analysis.The run data file analysis did not show a root cause for the donor¿s adverse reaction.However, it is possible that the donor experienced a vasovagal response which may have been caused by donor dehydration,the ¿return pressure high¿ alert that was generated during rinseback, or a combination of the two.The trima accel automated blood collection system operator's manual states the following caution: "the trima accel system has many safety features.However, a donor reaction can occur rapidly.Therefore, it is imperative that the trima accel system and the donor be monitored throughout the procedure.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury in the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3881911
• MDR Text Key: 4595085
• Report Number: 1722028-2014-00240
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK120049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/21/2014

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: 03/01/2016
• Device Catalogue Number: 000000000000080301
• Device Lot Number: 03W9115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 06/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/15/2014; 10/07/2014; 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2014
• 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): Required Intervention
• Patient Weight: 80