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

Catalog Number C-CB-1000

Device Problems Material Deformation (2976); No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 preparation for an endoscopic vein harvesting procedure, they noticed blower mister with iv sets tubing was pinched which restricted flow throughout the tube.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, they noticed blower mister with iv setstubing was pinched which restricted flow throughout the tube.No patient involvement.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Internal complaint # (b)(4).Autonumber # (b)(4).The certificate of conformance was reviewed.The vendors conform that the device lot conforms to all applicable product specifications.There were no non-conformities observed.Specific actions for the reported failure mode are being maintained and documented under maquet's health hazard evaluation (hhe) system.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, they noticed blower mister with iv setstubing was pinched which restricted flow throughout the tube.No patient involvement.

• Brand Name: BLOWER MISTER WITH IV SETS
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8179324
• MDR Text Key: 131140973
• Report Number: 2242352-2018-01310
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K983135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: C-CB-1000
• Device Lot Number: 96255609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1