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

Catalog Number C-CB-1000

Device Problems Disconnection (1171); Inadequacy of Device Shape and/or Size (1583)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 2015 09:59 am (gmt-4:00) added by (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.

Event Description

The hospital reported that during coronary artery bypass procedures, the blower mister with iv sets keeping popping off on the distal end where it connects to the co2 tank.Hospital states it doesn't happen with any particular surgeon, but happens on every case where they use one.Also the team has to tape the device where it connects with co2 tank, to keep from popping off.The hospital did not report any patient effects.The distal end where the tubing connects to the co2 tank, keeps popping off.The company representative was notified yesterday that this has been happening on every case.It was not just one case.The cases were finished by the circulators taping the distal end to co2 canister.There christmas tree connector was investigated and it was noticed it was smaller than normal and could be cause of problem.The company representative went to the respiratory department to get larger connectors.This could fixed problem, as we opened a blower mister and noticed that tubing did not pop off.

Manufacturer Narrative

(b)(4).A lot history record review was completed for lots 96255506, 96255515 and 96255524 the last 3 lots shipped to the account distributor prior to the event date.There was no nonconformance recorded in the lot history.(b)(4).

Event Description

The hospital reported that during coronary artery bypass procedures, the blower mister with iv sets keeping popping off on the distal end where it connects to the co2 tank.Hospital states it doesn't happen with any particular surgeon, but happens on every case where they use one.Also the team has to tape the device where it connects with co2 tank, to keep from popping off.The hospital did not report any patient effects.The distal end where the tubing connects to the co2 tank, keeps popping off.The company representative was notified yesterday that this has been happening on every case.It was not just one case.The cases were finished by the circulators taping the distal end to co2 canister.Their christmas tree connector was investigated and it was noticed it was smaller than normal and could be cause of problem.The company representative went to the respiratory department to get larger connectors.This could fixed problem, as we opened a blower mister and noticed that tubing did not pop off.

• 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: 5064116
• MDR Text Key: 25906953
• Report Number: 2242352-2015-01055
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CB-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1