MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 3 PUMP; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Lot Number 5301000ND

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2022

Event Type  malfunction  

Event Description

When attempting to run cardioplegia to the field, the cardioplegia pump generated an alarm.It was cleared multiple times and still was not functional.The cardioplegia pump was exchanged with another and the case continued without incident.Fda safety report id # (b)(4).

• Brand Name: MPS 3 PUMP
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): QUEST MEDICAL, INC.
• MDR Report Key: 14787709
• MDR Text Key: 294670921
• Report Number: MW5110455
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/19/2022

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 Lot Number: 5301000ND
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male