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

Catalog Number 000000000000080440

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2015

Event Type  Injury  

Event Description

The customer reported that during the first return cycle of a platelet donation procedure, the operator noticed air in the return line to the patient.The clamped the return line and stopped the procedure.Per the medical director's order, 911 emergency response was called.When the paramedics arrived, the donor refused treatment as she felt 'fine'.Per the customer, the donor remained at the center for approximately 45 minutes.The donor felt fine and left the center.Patient's (donor) full identifier: (b)(6).

Manufacturer Narrative

Investigation: the disposable set contained with blood was returned for investigation.Upon visual inspection, a small amount of air between the bottom of the return reservoir and the return pump tubing was noted.No clots were observed in the return reservoir or the remaining disposable.The set was visually inspected for kinks, missing parts, mis-assembly and occlusions, none were found.The run data file (rdf) was analyzed for this event.The analysis of the run data file did not find any conclusive cause for the air in the return line reported for this collection.No unusual process variable was identified and the signals in the run data file indicate that the triam accel system operated as intended.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a service call was placed and a full machine checkout was performed.The machine is functioning per manufacturer's specification.An auto test and saline run were successfully performed.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the analysis of the run data file did not find any conclusive cause for the air in there turn line reported for this collection.No unusual process variable was identified and the signals the run data file indicate that the trima accel system operated as intended.Possible causes for air entering the set.Inadequate squeezing of drip chambers.Foam or air in the return line.

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 of the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4862939
• MDR Text Key: 19033379
• Report Number: 1722028-2015-00227
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: 000000000000080440
• Device Lot Number: 04Y1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• 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): Required Intervention
• Patient Age: 00061 YR
• Patient Weight: 84