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

Catalog Number 82321

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

Sterilization process review investigation: the customer returned a used trima disposable set for investigation.Visual inspection confirmed the presence of prime fluid throughout the set.Blood was present in the needle line, but had not been collected beyond the sampling line y connector.There was a large mount of air observed in the sample bag, visibly swollen.The volume of air was measured by syringe withdrawal at approximately 60ml.The run data file (rdf) was analyzed for this event.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: signals in the rdf confirmed that the ¿pressure test error¿ alert was generated in this procedure because after the set was positively pressurized and the system was monitoring how much pressure gets relieved when the pumps move slightly.In this event, the pressure relieved was more than expected, therefore generating the alert.The run data file analysis did not show a conclusive root cause for what generated this ¿pressure test error¿-alert, however, it is possible the pinch clamp on the sample bag line was not occluding the line properly.If the clamp on the sample bag line is not occluding properly during the tubing set test, air can have a pathway to enter the sample bag.The rdf analysis also did not show that the operator opened the clamps to remove air from the sample pouch after the alert was shown.

Event Description

The customer reported that after performing a venipuncture on a donor for a collection procedure, the operator opened the white clamps and observed air entering in the sample bag.Per the customer, the sample bag appeared ¿blown up¿.Due to eu personal data protection laws, the patient (donor) information is not available from the customer.Patient (donor) gender and weight were obtained from the run data file (rdf).This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET AUTO PAS, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6876798
• MDR Text Key: 86897670
• Report Number: 1722028-2017-00376
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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
• Report Date: 09/19/2017

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: 04/01/2019
• Device Catalogue Number: 82321
• Device Lot Number: 1704272231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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: 103