MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUART ARTERIAL FILTER MODEL HBF-140; FILTER, BLOOD, CPB, ARTERIAL LINE

Model Number 00175

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, at the (b)(6) in the (b)(6) it was reported that the arterial filter quart 00175 leaked heavily from the bottom during priming.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).Per the laboratory analysis report dated july 15, 2013 leakage testing was performed on the returned sample and it was confirmed that there was a leak in the welding cover near the red stop cock.Such leakages would be clearly detected in the 100% function test in production, however it is possible that the leak could appear later on due to inner stress in the material.(b)(4).

• Brand Name: QUART ARTERIAL FILTER MODEL HBF-140
• Type of Device: FILTER, BLOOD, CPB, ARTERIAL LINE
• 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 ; maquet medical system, usa; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4282887
• MDR Text Key: 5299614
• Report Number: 8010762-2014-00497
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K001787
• 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: 05/03/2013

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: Other
• Device Expiration Date: 01/05/2013
• Device Model Number: 00175
• Device Catalogue Number: 70000.0175
• Device Lot Number: 70087888
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2013
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2013
• Initial Date Manufacturer Received: 05/03/2013
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1