MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BEQ-01930311#QUADROX-ID PAD. O.FILT; DIFFUSIVE MEMBRANE OXYGENTATOR

Catalog Number 70105.0970

Device Problem Filtration Problem (2941)

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

Event Type  Injury  

Event Description

It was reported that after thirteen hours of support, the device clotted and required a change out.The pt was not on heparin and the device was not used with any maquet equipment.Sorin s5 was used.The device was changed out with no reported pt effect.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary ag received the device for eval on (b)(4) 2014.The investigation is still pending.A supplemental medwatch will be submitted when add'l info becomes available.(b)(4).

• Brand Name: BEQ-01930311#QUADROX-ID PAD. O.FILT
• Type of Device: DIFFUSIVE MEMBRANE OXYGENTATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: kehler strasse 31; rastatt 76437 ; 4719973435
• MDR Report Key: 4147185
• MDR Text Key: 20863854
• Report Number: 8010762-2014-00753
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2014,09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2014
• Device Catalogue Number: 70105.0970
• Device Lot Number: 70096328
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2014
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2014
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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