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

Model Number HQV 44500

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

Feb.12, 2016 03:29 pm (gmt-5:00) added by (b)(6): (b)(4).The product was requested to return and was not yet been received.The investigation is still pending.

Event Description

Feb.12, 2016 03:19 pm (gmt-5:00) added by (b)(6): during priming a leak was noticed between the arterial outlet of the oxygenator and the tubing pack.The customer has since notified us that they believe this error to have been induced by human error - over pressurization." (b)(4).

Manufacturer Narrative

The product was investigated.Visual inspection during visual inspection the fitting of the tubes and the consistency of the cable ties was okay.After removal of the cable ties it was determined that the tubes self were sitting a bit too loose on the outlet and inlet connectors of the oxygenator.Small scratches and damages were visible on the blood inlet and blood outlet connector.Tightness test: the tube connections were tested for tightness with 1 bar pressure.A leakage at the blood inlet connector was confirmed.No abnormality was detected at the blood outlet connector by the pressure value of 1 bar.As the pressure was raised up to 1.5 bar leakages on both tubing connections were confirmed (outlet and inlet connector).When the tubes were moved slightly an heavy escape of air bubbles within the water was visible.Based on this the failure "leak between the arterial outlet of the oxygenator and the tubing pack" was confirmed.Furthermore the device history record of the complained lot has been investigated and no abnormality was found.The most probable cause of the failure could be that the tubes were too much widened during assembly.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): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5435126
• MDR Text Key: 38773270
• Report Number: 8010762-2016-00076
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090533
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: HQV 44500
• Device Catalogue Number: 70102.1593
• Device Lot Number: 92172726
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1