MAUDE Adverse Event Report: QUEST MEDICAL, INC. MYOCARDIAL PROTECTION SYSTEM 3 ND; MPS 3 ND

Model Number 5301000ND

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Quest has received the suspect device, but has not completed its investigation.A supplemental report will be filed at the conclusion of this investigation.

Event Description

It was reported to quest that during a case, while delivering cardioplegia, the amount notification alerted the user that there was 10ml of arrest agent left in the cartridge.After the perfusionist pressed the refill button and pushed the drug into the cartridge, the button failed to appear allowing the user to continue the operation.The console had to be power cycled and re-primed in order to reactivate the arrest drug piston.After power cycling, the device functioned normally.

Event Description

It was reported to quest that during a case, while delivering cardioplegia, the amount notification alerted the user that there was 10ml of arrest agent left in the cartridge.After the perfusionist pressed the refill button and pushed the drug into the cartridge, the button failed to appear allowing the user to continue the operation.The console had to be power cycled and re-primed in order to reactivate the arrest drug piston.After power cycling, the device functioned normally.

Manufacturer Narrative

Quest could not duplicate the reported complaint condition.It will continue to monitor complaint trends for this product.Quest has concluded the investigation of this unit.

• Brand Name: MYOCARDIAL PROTECTION SYSTEM 3 ND
• Type of Device: MPS 3 ND
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002
• MDR Report Key: 12365296
• MDR Text Key: 268059082
• Report Number: 1649914-2021-00007
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 20634624531004
• UDI-Public: 20634624531004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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 Model Number: 5301000ND
• Device Catalogue Number: 5301000ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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
• Patient Sex: Female