MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA SEAL SAFE

Model Number 917100000

Device Problems Device Emits Odor (1425); Sparking (2595)

Patient Problems Headache (1880); Pain (1994); Skin Discoloration (2074); Electric Shock (2554)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

Initial reporter full email: (b)(6).Investigation: the machine was checked out at the customer site by a terumo bct service technician.The sealer head cover was missing and the customer stated it was removed following the incident to look at the sealer.The technician cleaned the upper and lower jaws of the sealer, and observed burn spots on both the upper and lower jaws.The cable was checked and no issues found.A visual inspection of the sealer power unit and the internal cables was performed with no issues found.Technician observed some sparking when the sealer head was closed without a tubing segment between jaws.No sparking was observed with tubing in place.Per the customer, the donor was disconnected at the time of the incident and he did not receive any shock while donating.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the operator was sealing lines following completion of a trima plateletapheresis with concurrent plasma collection and the operator received a shock via her left hand holding the tubing.Per the customer, they observed sparking and smelled a 'burning' odor after the shock.The operator was jolted by the shock and felt a pain up her neck which resulted in a headache and noticed a small black spot on her left middle finger.First aid was provided to the operator and per the medical director's order, the operator visited her obstetrician since she was 20 weeks pregnant.The customer reported that the operator is' okay'.The customer declined to provide patient (operator) weight.

Manufacturer Narrative

Investigation: a known hazard associated with the use of the seal safe is radio frequency (rf)burns to the operator.By placing one's finger next to the cutter/sealer head jaws during operation of the unit, the operator can receive an rf burn or what feels like a shock.The trima operator's manual cautions the operator to ensure that the sealing head and tubing are free of moisture before operating the seal safe to avoid possible electrical arching.In addition, manual warns the user to not place fingers within 1 inch of the seal safe's sealing jaws while sealing to avoid possibility of receiving a radio frequency burn.An internal report for this machine, shows no further related issues.Root cause: the root cause of this incident could not be definitively determined.Machine check-out showed the machine to be in good working order.

Event Description

The operator stated that her ob doctor determined the shock did not affect the pregnancy.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury of the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA SEAL SAFE
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5021752
• MDR Text Key: 24009183
• Report Number: 1722028-2015-00499
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK010006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 917100000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2003
• 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): Required Intervention
• Patient Age: 00031 YR