MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLS VENOUS CANNULA

Model Number PVL2955

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2014

Event Type  Injury  

Event Description

It was reported that a device was placed in a large pt and the length was not sufficient.The device did not reach the superior vena cava, which was confirmed with an echo that showed insufficient venous drainage.The device was removed and replaced.This was reported to be a robotic case.There was no reported pt effect.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal mfr of the device maquet cardiopulmonary (b)(4).Maquet cardiopulmonary (b)(4) provides product failures investigation, analysis and resolution for the device described in this report.The device was discarded by the hospital.

• Brand Name: HLS VENOUS CANNULA
• Type of Device: VENOUS CANNULA
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470-0000 ; 9737097753
• MDR Report Key: 3986858
• MDR Text Key: 4886928
• Report Number: 3008355164-2014-00128
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2014,06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVL2955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2014
• Date Manufacturer Received: 06/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR