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

Catalog Number 000000000000080440

Device Problems Unintended Ejection (1234); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

The customer reported a plasma spray leak in the centrifuge.No medical intervention was necessary for this event.The donor has shown no symptoms to date.No blood exposure was noted to either staff or donors.This lot was not used in production at the customer site, therefore no patient information exists for this report.The disposable set is not available for investigation because it was discarded by the customer.This report is being filed in response to the customer filing a medwatch report.

Manufacturer Narrative

Investigation: per the med watch report, multiple operators reported trima kit failures during collection of apheresis platelets.Dry blood spatter was visible in the centrifuge at the end of collection.The leak detection alarm did not activate.The customer stated that lot number 07w1102 was not used in production at blood source due to failures of similar lots.The lot was quarantined and a medwatch form was filed.Investigation is in-process.A follow-up report will be provided.(b)(4).

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: the customer¿s implication of this lot is due to a known manufacturing defect of the control y.This filed report is likely based on prior root cause information exchanged for identical failure modes previously reported by the customer.In the case of the manufacturing defect of the control y, the incomplete knit line was formed when the injection process did not allow for adequate resin transfer into the mold.This weakened area becomes the leak point.Corrective action: corrective action has been implemented at the customer's site for the manufacturing defect of the control y.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIM ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: robbin crafe ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392282
• MDR Report Key: 4244678
• MDR Text Key: 5012872
• Report Number: 1722028-2014-00448
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK130080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2014

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: 07/01/2016
• Device Catalogue Number: 000000000000080440
• Device Lot Number: 07W1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2014; 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2014
• 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