MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HMOD 70000-USA#QUADROX-ID ADULT; DIFFUSION MEMBRANE OXYGENATOR

Device Problems Coagulation in Device or Device Ingredient (1096); Filtration Problem (2941)

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

Event Type  Injury  

Event Description

Reference importer # (b)(4).

Manufacturer Narrative

(b)(4).Maquet provides product failure investigation, analysis and corrective actions for the device described in this report.The device was used in a manner not consistent with its labeling.A supplemental medwatch will be submitted if additional information becomes available.(b)(4).

• Brand Name: HMOD 70000-USA#QUADROX-ID ADULT
• Type of Device: DIFFUSION 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 dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3870159
• MDR Text Key: 17260789
• Report Number: 8010762-2014-00208
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 04/21/2014
• Initial Date FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1