MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIP; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MXH-1000

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

In response to cardioquip's "urgent medical device correction mch-1000 cooler heater" it was determined that our 3 cardioquip mch-1000 cooler heaters are contaminated.This was verified through visual inspection and water testing.On (b)(6) 2022 heterotophic plate count, sm 9215b - 28000.Test unit: unk.Low test range: na.High test range: 500 cfu/ml.Our cleaning practices exceeded the manufacturer recommendation by performing monthly cleaning as opposed to recommended quarterly cleaning.We are in the process of returning our mch-1000s to cardioquip to be reconditioned.Fda safety report id # (b)(4).

• Brand Name: CARDIOQUIP
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP
• MDR Report Key: 13506437
• MDR Text Key: 285531080
• Report Number: MW5107352
• Device Sequence Number: 2
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/07/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MXH-1000
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1