MAUDE Adverse Event Report: MAQUET CV BLOWER MISTER WITH IV SETS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number C-CB-1000

Device Problem Material Integrity Problem (2978)

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

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 11:27 am (gmt-4:00) added by (b)(6) ((b)(4)): the device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, after opening the blower mister with iv sets, there was no iv connection part.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: BLOWER MISTER WITH IV SETS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5131902
• MDR Text Key: 28060484
• Report Number: 2242352-2015-01150
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K030512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: C-CB-1000
• Device Lot Number: 96255523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1