MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS MYOCARDIAL PROTECTION SYSTEM DELIVERY SET; CARDIOPULMONARY BYPASS HEAT EXCHANGER

Model Number 5001102

Device Problems Fluid/Blood Leak (1250); Failure to Prime (1492)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

The hospital perfusionist reported an issue encountered with the mps delivery set during a procedure.She reported that the mps console would not pass the initial priming steps with the delivery set leaking (either blood or a clear fluid).The initial information provided stated that the mps alarm/failure to pass prime was related to the alleged delivery set leakage.The perfusionist stated this event has occurred twice with 2 separate lot numbers (see also manufacturer report number 1649914-2014-00062).There were no patient complications reported as a result of the alleged event.The hospital has indicated the delivery set will be returned to the manufacturer for evaluation; however, the set has not yet been received.No additional information is available at this time.

Manufacturer Narrative

Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.

Manufacturer Narrative

Device evaluation found that the top heat exchanger housing/aa port appeared to have been produced at the supplier at the higher end of the range.This may have resulted in a hairline gap between the male luer of the check valve and the inner dimension of the additive port.During simulated use testing on an in-house console, only a miniscule leak was observed with the test sample.A cpar has been initiated with the supplier to modify the core pins used in the manufacturing process to bring closer to the nominal value for the housing.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: MPS MYOCARDIAL PROTECTION SYSTEM DELIVERY SET
• Type of Device: CARDIOPULMONARY BYPASS 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: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 4393062
• MDR Text Key: 5120004
• Report Number: 1649914-2014-00063
• Device Sequence Number: 1
• Product Code: DTR
• 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
• Type of Report: Initial,Followup
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/02/2017
• Device Model Number: 5001102
• Device Lot Number: 0475504C03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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
• Patient Outcome(s): Required Intervention