MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC WITH BIOLINE COATING; PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR

Device Problems Partial Blockage (1065); Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and corrective actions for the device described i this report.A supplemental medwatch will be submitted when additional info becomes available.(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC WITH BIOLINE COATING
• Type of Device: PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3573296
• MDR Text Key: 4142906
• Report Number: 8010762-2014-00002
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 12/10/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1