MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. HERC III 360; UNIVERSAL STABILIZER ARM

Model Number 001-401-160

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the arm is not stable.End of the arm to which the stabilizer is fixed is not stable and no longer holds the stabilizer.It is unknown if there was a delay in the procedure, if there was blood loss and if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.

Manufacturer Narrative

The returned sample was visually inspected, during which it was discovered that the expiration date had passed prior to the event date of this complaint.Upon evaluation of the sample, it was confirmed that the collet of the arm would not tighten around a ball attachment of an atlas or titan as it should when the cable wasn't tightened.Once the cable was tightened, as it would be during use, the attachment was completely stable within the arm.As the hercules arm is a reusable device, and the arm allows disposable attachments and stabilizers to be installed and removed to the collet, it is likely that damage occurred to the collet, pushing the prongs out and over time, moving the prongs outward so that they no longer had a tight fit around the ball attachments.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HERC III 360
• Type of Device: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6397039
• MDR Text Key: 69755941
• Report Number: 1124841-2017-00038
• Device Sequence Number: 0
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 001-401-160
• Device Catalogue Number: N/A
• Device Lot Number: 70680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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