MAUDE Adverse Event Report: MAQUET CV BLOWER MISTER WITH IV SETS; LAVAGE, JET

Catalog Number C-CB-1000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a coronary artery bypass procedure, blower mister with iv sets mixed mist did not come out from tip.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).Corrected sections: internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Signs of clinical use with no evidence of blood were observed.A visual inspection was conducted.No non conformities were observed.A mechanical evaluation was conducted.Following the instructions in ifu ((b)(4), instruction for use), the braided (0.64cm) tube was connected to the regulated source of c02 set with not more than 50 psi.The flow control for the saline was adjusted between 5 l/min (0.08 l/s).Care was taken that it doesn't exceed 8 l/min.The pinch clamp on iv tubing was closed and the iv spike was connected to a new bag of sterile saline with pressure cuff around it.After opening the pinch clamp the sterile saline and c02 gas started to flow simultaneously through the iv tubing.We were able to adjust the sterile saline flow to 1-5 (ml/min) and the flow of c02 gas with the help of the rollers.The sound of the c02 gas was heard at the atraumatic tip while coming out of the tube.No improper flow/infusion for the co2 gas was observed.Based on the results of the evaluation, the reported failure mode "improper flow/infusion" was not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, blower mister with iv sets mixed mist did not come out from tip.The hospital did not report any patient effects.

• Brand Name: BLOWER MISTER WITH IV SETS
• Type of Device: LAVAGE, JET
• 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: 6595332
• MDR Text Key: 76185503
• Report Number: 2242352-2017-00523
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K030512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: C-CB-1000
• Device Lot Number: 96255568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2016
• 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