MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS DELIVERY SET; CPBP HEAT EXCHANGER

Model Number 5001102

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

The sample has been received, but analysis of the sample has not yet been completed to date.Quest will file a supplemental report at the conclusion of the investigation.

Event Description

It was reported to quest medical by (b)(6) of an alleged issue with product code 5001102.In the report, it was stated that blood was allegedly observed in the heat exchanger.It was confirmed that there were no patient complications.Lot number of the device was not reported.

Manufacturer Narrative

The device was received by quest medical, inc.On 05/26/2023.Visual inspection confirmed the presence of blood on the top flange of the heat exchanger.It was also noted that the bellow within the hex had a deep indentation in its neck where the blood pooled.The root cause was inferred to be due to the deep neck during molding by the supplier, leading to inadequate glue application to prevent leakage.Quest will continue to monitor this complaint condition.Quest has concluded its investigation.

• Brand Name: MPS DELIVERY SET
• Type of Device: CPBP HEAT EXCHANGER
• 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 ; 9723326311
• MDR Report Key: 17128549
• MDR Text Key: 317876463
• Report Number: 1649914-2023-00018
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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: 5001102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1