MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BEQ-HMOD30000-USA#QUADROX-ID PAD.O.FILT; DIFFUSIVE MEMBRANE OXYGENATOR

Model Number 70105.0330

Device Problems Out-Of-Box Failure (2311); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Not Applicable (3189)

Event Date 10/31/2014

Event Type  malfunction  

Event Description

It was reported the customer received beq-hmod30000, but inside of the box the eight oxygenator's were all softline coated.Incident occurred out of box, prior to patient contact.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) is aware of this failure and has initiated the following actions: immediate action: shipping hold of potentially affected products by 10/22/2014.Inspection of labels for products under ship hold was initiated on 10/23/2014.Field safety corrective action (#2014-10-23) recall of mcp lot #70100610, article beq-hmod-3000-usa from the usa by 10/23/2014.Maquet cardiopulmonary (b)(4) has received the signed confirmation from the customer that the eight impacted pieces will be returned.

• Brand Name: BEQ-HMOD30000-USA#QUADROX-ID PAD.O.FILT
• Type of Device: DIFFUSIVE MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4316738
• MDR Text Key: 5207671
• Report Number: 8010762-2014-01332
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 70105.0330
• Device Lot Number: 70100610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 8010762-11/03/2014-001R
• Patient Sequence Number: 1