MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II DRIVE MECHANISM; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number UA-5001

Device Problem Corroded (1131)

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

Event Type  malfunction  

Event Description

The hospital reported that ultima activator ii reusable drive mech had corrosion on surface.The sterilization process was the following: first, mechanical cleaning and disinfection.Second chemical use of (b)(6) mediclean advanced.Third, thermal disinfection a0 value 3000.Fourth, steam sterilization 134° c - 5 minutes.There was no patient involvement.

Manufacturer Narrative

Tw id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h10, h11.Corrected sections: d4--serial # corrected from "(b)(6)" to "asku" as the serial number is unknown.The device was returned for evaluation on 02/29/2024.Photographs were provided by the account.A photographic evaluation was conducted.Signs of clinical use and no evidence of blood was observed.Corrosions was observed on the device.There were no other visual defects observed.An investigation was conducted on 03/05/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.Corrosions was observed on the device.Based on the photographic evaluation, as well as the evaluation results., the reported failure "corroded" was confirmed.The reported device is an oem device, therefore, a lot history review was not applicable.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

Event Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).H6--type of investigation: code "4109" added.Corrected sections: h6--type of investigation: code "3331" should be discarded as it was not performed.

• Brand Name: ULTIMA ACTIVATOR II DRIVE MECHANISM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 18676764
• MDR Text Key: 336224990
• Report Number: 2242352-2024-00083
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

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 Operator: Health Professional
• Device Model Number: UA-5001
• Device Catalogue Number: UA-5001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/20/2024; 04/02/2024
• Supplement Dates FDA Received: 03/20/2024; 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose