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

Model Number 5001102

Device Problems Air Leak (1008); Difficult to Remove (1528); Connection Problem (2900); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An investigation is being conducted into the alleged issues.A follow-up medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding alleged issues encountered during use of the mps delivery set.The report states that excessive plastic was seen on the disposable set which prevented the heat exchanger door from closing.The plastic was trimmed off both sides and this resolved the issue but caused delays to the procedure.The report also states that a seized connection issue was encountered when trying to switch from antegrade to retrograde cardioplegia.The surgeon tried to remove the seized connection with his fingers and was unable to.He then tried to remove it with some clamps which broke the plastic in the connection and caused air to be sucked into the aorta.The aortic cross clamp was on so no air went in systematically.There were no reported patient complications as a result of the alleged issues.

Manufacturer Narrative

Components of the complaint sample were returned for evaluation.The complete set was not returned.A dhr review did not identify any manufacturing anomalies related to the reported complaint.Manufacturing records reviewed indicate the device was within specifications.The root cause of the excessive plastic reported on the disposable set is unknown.Device evaluation showed the internal threads of the male luer lock were found to be damaged with such damage possibly resulting from overtightening by the end user.Quest medical will continue to monitor complaints for trend.

• 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: 7248183
• MDR Text Key: 99800182
• Report Number: 1649914-2018-00019
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 5001102
• Device Lot Number: 0547227N02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention