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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was evaluated and was confirmed to be leaking around the diaphragm area and bottom housing.Three additional samples, similar to the complaint sample, were pulled from existing inventory and these samples were leak tested for 24 hours.No leak was observed on any of the additional samples.A dhr review was conducted and there were no manufacturing anomalies associated with the reported complaint condition.The definite root cause of the reported complaint condition is unknown.A potential root cause might be a shift in the diaphragm, which may have created the potential for bond strength degradation and material separation between the diaphragm and the bottom housing components where the leak was observed.Quest will continue to monitor complaint trend.

Event Description

A report was received regarding an alleged issue encountered during use of the mps delivery set.The report states that during a procedure, the delivery set leaked when delivering cardioplegia during bypass.The delivery set was changed out without any patient complications resulting from the alleged incident.

• Brand Name: MPS DELIVERY SET
• Type of Device: CPBP HEAT EXCHANGER
• 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: 8880750
• MDR Text Key: 162885334
• Report Number: 1649914-2019-00042
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2019

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: 0580089A04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention