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

Model Number 5201260

Device Problems Air Leak (1008); Solder Joint Fracture (2324); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the device has not been received for evaluation.A follow-up medwatch will be filed if further information becomes available.

Event Description

A biomedical engineer from (b)(6) reported an issue with the console.His report states that the console displayed the error code "air in the heat exchanger" and the vent line had to be manually clamped to complete the case.There were no patient complications reported as resulting from the alleged issue.

Manufacturer Narrative

The console was received and the reported complaint was duplicated.The unit was opened and checked for defects, fluid intrusion and damage.The fluid level sensor was found to be problematic and was replaced.This resolved the issue.The console was reassembled and it passed all functional testing.The root cause of the broken solder joint may be due to the end user tapping on the heat exchanger during priming to de-bubble.

• Brand Name: MPS 2 CONSOLE
• Type of Device: CPBP HEAT EXHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 6989214
• MDR Text Key: 91219384
• Report Number: 1649914-2017-00086
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention