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

Catalog Number 82420

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf did not show a definitive root cause for the reported access pressure alarms throughout the procedure.At 6 minutes into the run, analysis of the pressure signals showed an increase in the access pressure values (more negative) until both the access and return alarm limits were reached repeatedly.In this procedure, the pressure in the donor¿s vein did not fully recover when the continue button on the ¿high return pressure¿ alert screen was pressed at 17 minutes into the procedure, and therefore access alerts were repetitively generated in the next cycles.It is possible that the donor moved or the needle was repositioned at this point, causing the pressure increase/decrease.The rdf analysis shows that the access alerts generated appeared to be due to true donor access related issue based on pressure signals.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure the donor experienced hematomas.It is unknown at this time if medical intervention was required for this event.Patient (donor) information and outcome is not available at this time.Donor's gender and weight were obtained from the run data file (rdf).The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: this disposable was unavailable for specific root cause analysis.A definitive root cause was not determined.Possible causes include, but not limited to, poor phlebotomy technique, donor physiology, or rapid return flows.Review of the run data file did not show a definitive root cause for the reported access pressure alarms throughout the procedure.At 6 minutes into the run, analysis of the pressure signals showed an increase in the access pressure values (more negative) until both the access and return alarm limits were reached repeatedly.In this procedure, the pressure in the donor¿s vein did not fully recover when the continue button on the ¿high return pressure¿ alert screen was pressed at 17 minutes into the procedure, and therefore access alerts were repetitively generated in the next cycles.It is possible that the donor moved or the needle was repositioned at this point to cause the pressure increase/decrease.Run data file analysis showed that the access alerts generated appeared to be due to true donor access related issue based on pressure signals.

Event Description

The customer stated that the donor was given conservative therapy which did not include any surgical procedures.Due to eu personal data protection laws, the patient identifier and age are not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC WITH AUTO PAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6563384
• MDR Text Key: 75039919
• Report Number: 1722028-2017-00182
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 82420
• Device Lot Number: 10Z1119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2016
• 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: 90