MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS BACK-UP SYSTEM; CARDIOPLEGIA DELIVERY SYSTEM

Model Number 5001017

Device Problems Failure to Deliver (2338); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident occurred outside of the us.This medwatch is being submitted because a similar device is distributed by quest medical in the us.As of the date of this report, it is not known if the device will be returned for evaluation.A follow up medwatch will be submitted if additional information becomes available.

Event Description

During a regular in-hospital check, a medical staff tried to turn the wheel of the backup system but it did not work.The device was not used in surgery and there were no patient complications resulting from the issue.

Manufacturer Narrative

The device was evaluated and the center belt associated with piston movement was found broken.The broken pitch belt was replaced with a new belt and the unit was calibrated.The device was tested following the belt replacement and it passed all testing.The root cause of the broken pitch belt is unknown.

• Brand Name: MPS BACK-UP SYSTEM
• Type of Device: CARDIOPLEGIA DELIVERY SYSTEM
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: one allentown parkway; allen, TX 75002
• MDR Report Key: 7538981
• MDR Text Key: 109116248
• Report Number: 1649914-2018-00049
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 5001017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1