MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER; CARDIOPULMONARY BYPASS DEVICE

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2019

Event Type  malfunction  

Event Description

Multiple cardiac surgery and ecmo hosps in (b)(6) and (b)(6) experiencing serious product issues with heater/cooling units reliability and quality manufactured by cardioquip llc.I travel to many hosps in these states and have heard and seen the cardioquip llc mch-1000 device pulled from treatment rooms due to devices inability to rewarm pts on cardiopulmonary bypass.Most hosps reporting the same issues with the mch-1000 devices.The inability for the device to properly perform may lead to extended time pts need to remian on cpb to be returned to normal body temperature.

Manufacturer Narrative

The manufacturer is reporting the following complaint after voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.Cardioquip was made aware of a report submitted through fda's medwatch program.The report does not identify the device(s) involved or other essential information required for cardioquip to investigate the reported event.Cardioquip is reporting this event to respond to the medwatch report submitted previously.

• Brand Name: CARDIOQUIP MODULAR COOLER HEATER
• Type of Device: CARDIOPULMONARY BYPASS DEVICE
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct.; college station TX 77845
• Manufacturer (Section G): CARDIOQUIP, LLC; 8422 calibration ct.; college station TX 77845
• Manufacturer Contact: charley ford ; 8422 calibration ct.; college station, TX 77845 ; 9796910202
• MDR Report Key: 15606571
• MDR Text Key: 305539757
• Report Number: 3007899424-2022-00146
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K102147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1