MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY HQV 51100# ADULT PRE-CONNECTED PACK; RESERVOIR

Model Number 70102.6914

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/16/2014

Event Type  Injury  

Event Description

It was reported that bypass and the venous line were initiated.A large volume of blood was observed entering the reservoir from the three suckers.Blood was observed exiting from the top of the filter housing of the reservoir.(b)(4).

Manufacturer Narrative

The device has not been received for evaluation.A follow up medwatch will be sent when additional information becomes available.

Manufacturer Narrative

The sample is not available for investigation.According to the provided video the failure can be confirmed.Device failure cannot be confirmed.Similar complaints should be observed.For the time being no further investigation will be performed.The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.(b)(4).

• Brand Name: HQV 51100# ADULT PRE-CONNECTED PACK
• Type of Device: RESERVOIR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4435846
• MDR Text Key: 5393167
• Report Number: 8010762-2015-00016
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 70102.6914
• Device Lot Number: 92148289
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention