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

Catalog Number 70105.0330

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

It was reported that a box of 4 were labeled "soft line" and the product pouch was labeled "bioline".No patient involvement.(b)(4).

Manufacturer Narrative

Photos sent by the customer indicate that the first and second outer box coating label were incorrect (labeled with softline).It was determined that the boxes should have been labeled with a bioline label.The product and the pouch itself were labeled correctly with a bioline label.This was confirmed upon sample receipt.Immediate action: a shipping hold of potentially affected products was initiated (b)(4) 2014.Quarantine and 100% inspection of potentially impacted products was initiated (b)(4) 2014.Field safety corrective action (#(b)(4)) recall of mcp lot #70100610, article beq-hmod-3000-usa from the usa by 10/23/2014.Maquet cardiopulmonary ag will initiate a capa to address the appropriate corrective and preventive action.

• 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: 4260796
• MDR Text Key: 5050816
• Report Number: 8010762-2014-01272
• 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: 10/15/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 70105.0330
• Device Lot Number: 70100610
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 11/14/2014
• 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
• Patient Sequence Number: 1