MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 70102.7652

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 at the (b)(6) in (b)(6) it was reported that after a perfusion procedure when the silicone tubing used with the hl20 single roller pump module serial number (b)(4) was removed from the pump head there was a cut in the same location as that which occured on (b)(6) 2014.The cut did not penetrated the entire wall of the tubing.The other event reported in this complaint is being submitted in a separate medwatch (8010762-2015-00500).(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A evaluation of the returned single roller pump and tubing set was performed in the engineering laboratory using the worst case scenario of the highest occlusion setting.The reported issue was able to be reproduced with only the medtronic tubing set that was being used when the event occured.The cause was determined to be an sharp edge of the pump head that over time wears out the tubing.The design of the pump head was revised to smoothen out the sharp edge.(b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4944702
• MDR Text Key: 6193491
• Report Number: 8010762-2015-00615
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2014,01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.7652
• Device Catalogue Number: MCP00703309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2014
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1