MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXY.; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-PLS 2050

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013 at the (b)(6) hospital in (b)(6) it was reported that even with a activated clotting time of 220 seconds after 36 hours of use there was clotting observed on the be-pls 2050 oxygenator from lot number70089359.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The returned sample was analyzed by pressure testing in the laboratory and it failed the blood side pressure drop test specification.The pressure drop was higher than the maximum specified 100 mmhg.(b)(4).

• Brand Name: QUADROX-ID ADULT DIFFUSION MEMBRANE OXY.
• Type of Device: OXYGENATOR, 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: 4944811
• MDR Text Key: 21057389
• Report Number: 8010762-2015-00478
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K101153
• 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: 09/23/2013

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: Health Professional
• Device Expiration Date: 06/10/2015
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 70102.7818
• Device Lot Number: 70089359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2013
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2013
• Initial Date Manufacturer Received: 09/23/2013
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• 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