MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLS,RBC,TLR FILTER

Catalog Number 000000000000080483

Device Problems Air Leak (1008); Device Difficult to Setup or Prepare (1487)

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

Event Date 08/07/2014

Event Type  malfunction  

Event Description

The customer reported that during setup procedure, they noticed air was drawn into the sample bag and inflated with air.Per the customer, the sample bag line clamps were closed.Due to eu personal data protection laws, the patient information is not available from the customer.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for injury has occurred.

Manufacturer Narrative

Investigation: the disposable set was returned for investigation.Upon visual inspection, it was noted that the two white clamps on access line were closed and fully occluding the line.The sample bag was slightly inflated, but not full of air.No other misassemblies were noted.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.The run data file (rdf) was analyzed for this event.Root cause: the run data file analysis showed that the tubing set was loaded successfully and passed the disposable test.No alerts were generated.It is possible that air can enter the sample bag if tubing is slightly askew from the sample bag clamp, and therefore the clamp is not fully occluding the line during the disposable test.Correction: a voluntary medical device recall was released by terumo bct to communicate more information about "air in sample bag safety alert" to customers.Although the customer correctly saw air in the sample bag and ended the run before donor connect, customer training was performed regarding air in sample bag for additional awareness and customer follow up.Corrective/preventive action: an internal capa has been initiated to address air in the sample bag issues.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information in and to align with the reported event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLS,RBC,TLR FILTER
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4061386
• MDR Text Key: 19926389
• Report Number: 1722028-2014-00362
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 08/11/2014

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: 05/01/2016
• Device Catalogue Number: 000000000000080483
• Device Lot Number: 05W2121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 09/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/17/2014; 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other