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

Model Number 5001102

Device Problems Device Damaged Prior to Use (2284); Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The alleged incident took place in (b)(6).This medwatch is being submitted because quest distributes a similar device in the us.The device will be evaluated when it is received from the customer and a follow up medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding an alleged issue encountered during use of the mps delivery set.The report states that while priming the mps gave an inadequate inlet pressure message.It was cleared and the mps primed with no issues.While the pump was recirculating the user tried flushing the cardioplegia line to the table.The same alarm was seen and the alarm could not be cleared and the console would not flow forward.The console was changed out before going on bypass and the prime line was flushed to the sterile field.While flushing cardioplegia to the field, the same error message was seen and the user could not get forward flow.The inflow line to the mps was switched to the recirc line with a 1/4x1/4 connector but this did not resolve the error message.The disposable was thereafter changed and this resolved the alarm.There were no patient complications resulting from the alleged incident.

Manufacturer Narrative

The device was received and the complaint condition was confirmed.The tubing on the blood side of the pump cassette was assembled too far into the bushing and this resulted in the "inadequate fill" alarm as reported.A quality alert was issued as a corrective action.Quest will continue to monitor trends for the reported complaint condition.

• 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: 8597384
• MDR Text Key: 146360794
• Report Number: 1649914-2019-00026
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• 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: 0575809F05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2019
• 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