MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 2 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 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

Quest medical has not yet completed its investigation of this device.A follow-up report will be filed at the conclusion of its investigation.

Event Description

It was reported to quest medical by cosmotec japan of an alleged issue with mps 2 disposable set, product code 5001102.The report stated that there was an alleged blood leak at the pressure sensor of the mps 2 delivery set.It was confirmed that there were no patient complications.

Manufacturer Narrative

The suspect device was received by quest medical.Testing of the device at 10psi while submerged underwater revealed bubbles emerging from the diaphragm.The complaint condition of leaking was confirmed.The root cause was determined to be due to a breakdown of the glue path at the diaphragm, likely due to extended priming time.The user is instructed to not prime the device for more than 12 hours in order to avoid this failure mode.Quest has concluded its investigation into this device.Quest will continue to monitor trends for this complaint condition.

• Brand Name: MPS 2 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: 16792006
• MDR Text Key: 313962375
• Report Number: 1649914-2023-00015
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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
• Device Lot Number: 67375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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