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

Catalog Number 70105.0758

Device Problem Filtration Problem (2941)

Patient Problems Respiratory Distress (2045); No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2014

Event Type  Injury  

Event Description

According to the customer: patient with right lung disease/ards connected to ecmo circuit.After 1 day, clotting developed and the oxygenator was exchanged.No critical consequences were reported for the patient.(b)(4).

Manufacturer Narrative

(b)(4).The manufacturer has received the device for investigation on june 26, 2014.The investigation result is still pending.A supplemental medwatch will be submitted when further information becomes available.

• Brand Name: BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER
• Type of Device: DIFFUSIVE MEMBRANE OXYGENATOR
• 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 pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3975690
• MDR Text Key: 18362301
• Report Number: 8010762-2014-00257
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2014,07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: 70105.0758
• Device Lot Number: 70097398
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2014
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR