MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS CANNULAE & PIK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Vessels (2135)

Event Type  Death  

Event Description

The following information was obtained by getinge sales & service representative whiie gathering information for complaint mcp ref.(b)(4) (mfg report number 8010762-2024-00184).The reported failure had occurred on the same patient and during the same event with complaint mcp ref.(b)(4) (mfg report number 8010762-2024-00184).It was reported that a blood vessel was lacerated when a hls cannulae was inserted.The cause of the damage was reported as cannulation procedure complications by customer.Patient expired during treatment.Complaint #(b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when further information becomes available.H3 other text : 4115.

• Brand Name: HLS CANNULAE & PIK
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 19181827
• MDR Text Key: 341046607
• Report Number: 3008355164-2024-00014
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2024
• Distributor Facility Aware Date: 04/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death