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

Catalog Number 80420

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Analysis of the rdf confirmed that the centrifuge pressure high alert occurred early in the run at 2.6 minutes.Based on the event description, the operator may have closed the baby clamps on the tubing lines that exit the centrifuge.If any of these clamps were closed during collection, it is possible for a centrifuge pressure high alert to occur as fluid cannot exit to the reservoir as expected.When the centrifuge stops during the blood prime sequence, it is possible for air to enter and block the plasma and platelet lines.The multiple ¿return too short¿ alerts were likely caused by the air and fluid mixture in the lines due to the centrifuge stop.The operator correctly performed an air block recovery at 8 minutes into the procedure which did allow plasma to pass by the rbc detector however signals confirm air was also in the line which may be indicative that another air block recovery should be performed or one or more of the baby clamps were still closed.Upon inspection of a photograph provided by the customer, foam was observed in the reservoir, which it may have been mistaken for an air bubble returning to the donor.Based on the pictures provided, air cannot be seen in the return line until after the tubing set had been unloaded.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported at the beginning of a donation procedure, they received multiple alarms including red blood cell (rbc) detector and rbc spill-over alarms and noticed foam from the centrifuge in the plasma line.While the rn performed several adjustments for 'air blocks', she observed air bubbles in the return line.She stopped and aborted the procedure.The donor was monitored and checked throughout the day.No medical intervention was required for this event.The customer stated that the donor is 'okay'.Patient (donor) id and age are not available at this time.The donation set is not available for return because it was discarded by the customer.

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.Root cause: a definitive root cause could not be determined.Analysis of the run data file confirmed that the centrifuge pressure high alert occurred early in the run at 2.6 minutes.Based on the complaint description the operator may have closed the baby clamps on the tubing lines that exit the centrifuge.If any of these clamps were closed during collection, it is possible for a centrifuge pressure high alert to occur as fluid cannot exit to the reservoir as expected.When the centrifuge stops during the blood prime sequence, it is possible for air to enter and block the plasma and platelet lines.The multiple ¿return too short¿ alerts were likely caused by the air and fluid mixture in the lines due to the centrifuge stop.The operator correctly performed an airblock recovery at 8 minutes into the procedure which did allow plasma to pass by the rbc detector however signals confirm air was also in the line which may be indicative that another airblock recovery should be performed or one or more of the baby clamps were still closed.The trima system is designed such that air in the kit will go into the reservoir and be contained in the vent bag attached at the top of the reservoir.The return pump pulls fluid from the bottom of the reservoir and starts when fluid is seen at both the upper and lower reservoir sensors.Since there was foam in the reservoir (confirmed by the photos provided), it may have been mistaken for an air bubble returning to the donor.Based on the pictures provided, air cannot be seen in the return line until after the tubing set had been unloaded.

Event Description

Due to eu personal data protection laws, the patient identifier and age are not available from the customer.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,RBC,AUTO PAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6011863
• MDR Text Key: 57360434
• Report Number: 1722028-2016-00559
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: BK150321
• 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: 10/07/2016

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: 07/01/2018
• Device Catalogue Number: 80420
• Device Lot Number: 07Z1307
• Other Device ID Number: 05020583804203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2016
• 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 Weight: 80