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

Catalog Number 5804001

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct's system engineer performed a calculation for the potential forac overinfusion and hypovolemia for this event.The calculated ac infusion rate is less than the maximum allowed ac infusion rate per the version 6.0 trima accel system administrator¿s guide.Therefore, it is unlikely that an ac overinfusion occurred due to the incorrectly entered donor information.Based on the trima accel automated blood collection system administrator's guide, the total volume removed from the donor resulted in less than 15% tbv being removed.The used disposable set containing blood was returned to terumo bct for investigation.It was noted that product bags were not returned for evaluation.Fluid had circulated throughout the entire set and the return reservoir one-third full of fluid upon receipt.Visual inspection for kinks, occlusions, missing parts, misassembly or leaks which may have contributed to the reported incident did not reveal any abnormalities.All witness and wear marks indicate all loop and channel components were properly loaded.All pressure sensors were inspected and determined to be functioning properly.It was also noted that there were no signs of clumping or clotting in the set.Hemostats and tubing strippers were used to manipulate fluid throughout the set and no fluid flow issues were noted.A terumo bct technician checked out the machine at the customer site and found that the pinch valve arms were loose.The technician tightened the arms and successfully tested the valve assembly.The machine was returned to use.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that at the beginning of a triple platelet collection procedure, the operator programmed the trima machine to collect platelets.The machine began to collect, but she noticed that blood was being collected into the plasma bag.The customer stated that 554 grams of plasma were collected and the donor left the customer's site with no apparent problems and no treatment was given since no problems were noted post donation.Patient's (donor) full identifier: (b)(6).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: root cause was undetermined at this time.It is possible, though not confirmed, that the plasma valve error contributed to this incident as the line may not have been fully occluded at the time.

Manufacturer Narrative

This report is being filed to provide additional information investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf showed a fluctuation in the reservoir volume.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, 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: 6688444
• MDR Text Key: 79668117
• Report Number: 1722028-2017-00278
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: 5804001
• Device Lot Number: 1612175351
• Other Device ID Number: 05020583804005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 07/25/2017; 04/17/2018
• Supplement Dates FDA Received: 07/28/2017; 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• 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: 57 YR
• Patient Weight: 97