MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 2 CONSOLE RENTAL; CPBP HEAT EXHANGER

Model Number 5201260RT

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

The console will be evaluated when it is received and a follow up medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding an alleged issue encountered during use of the mps console.The report states that during delivery of the first dose, the console displayed the error message "internal error".The console was removed from service and will return to quest medical for evaluation.There were no patient complications.

Manufacturer Narrative

Mps console was received and decontaminated.Upon power up, the console did not fail.This was repeated a few times to ensure that there was nothing to find wrong with the console.However, upon attempting to read the console's log data (through the use of the log data utility software via the rs-232 port connection), error code ec060 (health check error) was displayed.The log data was found to be corrupted and thus not available for review.The log data was deleted, which cleared the error code.The console successfully passed the operational verification testing.

• Brand Name: MPS 2 CONSOLE RENTAL
• Type of Device: CPBP HEAT EXHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 10759913
• MDR Text Key: 215098370
• Report Number: 1649914-2020-00037
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• PMA/PMN Number: K173716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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: No Information
• Device Model Number: 5201260RT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1