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

Catalog Number C-CB-1000

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2018

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 a coronary artery bypass procedure, blower mister with iv sets had missing tip or wrong position of tip, so it cannot be sprayed.The hospital implemented visual inpsection for their storage, but unfortunately all cb-1000 (12 q'ty) don't have plastic part in the tip.No patient involvement.

Manufacturer Narrative

Internal complaint number trackwise# (b)(4).Autonumber # (b)(4).Signs of clinical use and no evidence of blood was observed.The device was returned in the sterile barrier unopened indicating that the device was never used.There were no visual defects observed.The sterile barrier was opened to inspect the device.No non-conformities were observed with the blower mister.The fine mist tip and the saline tube appeared intact.There were no missing components.Based on the return condition of the device and the investigation results, the reported failure " component missing" is not confirmed.The certificate of conformance ( c of c) was reviewed for the reported lot number.The vendor certifies that the device lot conforms to all product specifications and requirements.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, blower mister with iv sets had missing tip or wrong position of tip, so it cannot be sprayed.The hospital implemented visual inspection for their storage, but unfortunately all cb-1000 (12 q'ty) don't have plastic part in the tip.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: 7645413
• MDR Text Key: 112848351
• Report Number: 2242352-2018-00610
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K030512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: C-CB-1000
• Device Lot Number: 96255589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1