MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACCESSRAIL PLATFORM (STANDARD BLADE); INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number SB-1000

Device Problem Insufficient Information (3190)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

The hospital reported that the sb-1000 standard blades malfunctioned and it wasn't working properly.No injury to the patient was reported.

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.

Event Description

The hospital reported that the sb-1000 standard blades (right) malfunctioned (didn't "hold in place" wouldn't lock )and it wasn't working proper.Opened another set of blades with same issue.Then opened another set with a different lot #.No injury to the patient was reported.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 3000293769 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and no specific failure was alleged for the reported device.Specific actions for the reported confirmed failure mode are being maintained and documented under maquet's scar system.There were no consequences or impact to the patient.H3 other text : device discarded.

• Brand Name: ACCESSRAIL PLATFORM (STANDARD BLADE)
• 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: 17396445
• MDR Text Key: 320621209
• Report Number: 2242352-2023-00605
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00607567700215
• UDI-Public: 00607567700215
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

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: SB-1000
• Device Catalogue Number: SB-1000
• Device Lot Number: 3000293769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1