MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUART ARTERIAL FILTER WITH SOFTLINE COATING; FILTER, BLOOD, CPB, ARTERIAL LINE

Model Number BO-00175

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012 at the (b)(6) hospital in (b)(6), it was reported that upon priming with crystalloid a leak was noticed at the inlet/bottom bypass diverter valve area of the housing of the arterial filter quart bo-00175.The customer also noted that this was a reoccurring problem in the same location of the filter housing.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).Per the final statement to the complaint letter dated december 14, 2012 leakage testing was performed on the returned sample, and it 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 WITH SOFTLINE COATING
• 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: 4283018
• MDR Text Key: 17218827
• Report Number: 8010762-2014-00471
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K090518
• 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: 09/26/2012

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: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: BO-00175
• Device Catalogue Number: 70103.2031
• Device Lot Number: 70075129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/26/2012
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2012
• Initial Date Manufacturer Received: 09/26/2012
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1