MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BO-HQV 15907

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2015 11:50 am (gmt-4:00) added by (b)(6) ((b)(4)): maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The investigation of the product in the laboratory of the manufacturer is still pending.A supplemental medwatch will be submitted when further information becomes available.Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-i neo.Which is registered under 510(k): (b)(4).

Event Description

The first perfusion run was a total of 5 hours and 47 minutes.The blood parameters were normal and we did not encounter any problems relating to gas values etc.The first bypass run was ended, the muf procedure applied and a short while later we were required to restart bypass due to poor haemodynamic status.On the onset of the second perfusion run it was noted that the gas exchange was very poor, a decrease in po2 values and an increase in co2 values with a gas flow of 700 ml sweep flow and 60% fio2, upon seeing this i increased the gas flow to 1 litre per minute, noted no improvement, then increased the gas flow to 2 litres, and then to 3 litres within the first minute, upon seeing very little improvement i increased the gas flow to 10 litres and the fio2 to a 100% setting.This seemed to have had the desired effect.It has to be stressed that the ventilation on the anaesthetic side was continued the whole of the second pump run to aid in our predicament and it was mainly due to the assistance from the anaesthetic side that we did not need to change out the oxygenator.(b)(4).

Manufacturer Narrative

(b)(6) 2015 05:30 pm (gmt-5:00) added by (b)(6) ((b)(4)): the product was tested according to lv 009 for its o2 and co2 transfer rate and was operating within its specifications.No abnormalities were found.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/SOFTLINE COATING
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5180444
• MDR Text Key: 29351521
• Report Number: 8010762-2015-01129
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K102464
• 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: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: BO-HQV 15907
• Device Catalogue Number: 70106.7041
• Device Lot Number: 92156715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2014
• 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