MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEARTSTRING III SYSTEM 4.3MM; CLAMP, VASCULAR

Model Number HSK-3043

Device Problem Fitting Problem (2183)

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

Event Date 03/04/2024

Event Type  malfunction  

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 when they tried to insert the hst iii system (4.3mm) into the cannula while loading, the seal did not fit properly, so they opened a new one and used it.The steps were done correctly, but the seal was left behind when they pulled out the device.Ope ended successfully.No delay.There was no harm to the patient.

• Brand Name: HEARTSTRING III SYSTEM 4.3MM
• Type of Device: CLAMP, VASCULAR
• 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: 18963490
• MDR Text Key: 338614661
• Report Number: 2242352-2024-00286
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130382
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HSK-3043
• Device Catalogue Number: HSK-3043
• Device Lot Number: 3000347059
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 10/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1