MAUDE Adverse Event Report: GYRUS ACMI, INC VC10 PUMP, 115V

Model Number VC-10

Device Problem Overfill (2404)

Patient Problem Blood Loss (2597)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined at this time.In addition, limited information regarding the reported patient, procedure and device was provided by the user facility.However, if additional information becomes available or if the device is returned to olympus for evaluation, this report will be supplemented accordingly.

Event Description

Olympus was informed during an unspecified procedure, the user facility reported they noticed the patient lost a lot of blood which then got into the over flow canisters of the device.

• Brand Name: VC10 PUMP, 115V
• Type of Device: VC10 PUMP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7387054
• MDR Text Key: 104029055
• Report Number: 2951238-2018-00227
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: VC-10
• Device Catalogue Number: VC-10
• Device Lot Number: N/A
• Other Device ID Number: UDI
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other