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

Model Number 5ND3102

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

It was reported to quest medical of an allegedly leaking mps delivery set.It was confirmed that there were no patient complications.

Manufacturer Narrative

An investigation on the suspect device is unable to be performed, as the device was discarded after the procedure.A review of the production records from the sample's lot was performed and no anomalies in the manufacturing process were noted.The complaint condition could not be confirmed.Quest will continue to monitor complaint trends for the reported condition.Quest has concluded its investigation of this complaint.

• 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: 15442565
• MDR Text Key: 300448052
• Report Number: 1649914-2022-00021
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00634624530348
• UDI-Public: 00634624530348
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022

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: 5ND3102
• Device Lot Number: 65386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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