MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER; D-QUADROX-I ADULT

Model Number BE-01970311-PLS

Device Problems Disconnection (1171); Connection Problem (2900)

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

Event Date 05/10/2012

Event Type  malfunction  

Event Description

The pt underwent a cardiac surgery and the same day he also underwent an ecmo procedure.After 8 days of using the set without any problems there was n arterial connector's detachment of the be-pls 2050.After that the team focus on ecmo procedure, replaced in emergency be-pls 2050 that was damaged with a new circuit, so the ecmo procedure continued for other 6 days more.No pt injury related to the detachment of the outlet connector reported.The oxygenator is a component of a be-pls 2050 # permanent life support set with an unk batch.Ref: (b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.This complaint is part of a capa (b)(4) and has not been reported due to "old" reporting policies and the oxygenator without coating is not sold in the us.The oxygenator itself, included in the pls tubing set has been glued with the same glue as the types of oxygenators which are sold in the us.The glue was changed in (b)(4) 2013 and the implementation was validated in (b)(4) 2013.Since then no further incidents related to connector detachments with the same root cause are known.A f/u report will not be issued.

• Brand Name: BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER
• Type of Device: D-QUADROX-I ADULT
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice krebs ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097359
• MDR Report Key: 3823776
• MDR Text Key: 4401850
• Report Number: 8010762-2014-00064
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112360
• 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: 02/20/2014,06/22/2012

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 Model Number: BE-01970311-PLS
• Device Catalogue Number: 70105.0758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2012
• Initial Date Manufacturer Received: 06/22/2012
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1