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

Model Number VKMO 31000

Device Problem Air Leak (1008)

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

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Feb.11, 2016 09:05 am (gmt-5:00) added by (b)(6): (b)(4).Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not yet received it.Investigation is still pending.

Event Description

Feb.11, 2016 08:51 am (gmt-5:00) added by (b)(6): description from the customer report: pediatric case where the bubble sensor on the s5 pump has been activated, cutting out the arterial roller pump.This occurred at the beginning of cpb within the first few minutes.The perfusionists involved followed the emergency air emboli procedure in a timely manner, to check and remove air from the circuit in order to safeguard the patient.The patient was isolated from the cpb circuit whilst the circuit was checked for air bubbles; none were seen at the oxygenator, arterial filter or bubble sensor.Air bubbles were seen at the arterial line/arterial cannula and were removed via disconnection of the arterial line.Air bubble sensor activated three times in succession.Cpb thereafter continued with no further incident.(b)(4).

Manufacturer Narrative

During investigation and visual inspection it was noticed that the tubes on blood inlet and blood outlet has not been connected correctly and cable tie's has been missing.No deformation of the connectors has been found.As the tubes have not been connected by the manufacturer no additional complaint will be open.Furthermore cracks on luer lock on de-airing valve of the oxygenators has been found.A tightness test has been performed.Thereby a leakage has been detected.No evidence was provided that this failure was noticed within the initial complaint report.An additional complaint was opened to evaluate this failure.No relation between leakage and the reported failure could be found by the manufacturer.Furthermore a device history record of the complained lot has been performed by maquet cardiopulmonary (b)(4).Thereby no abnormality was found.Based on the reported event and our investigation, the included product was used beyond the usage described in our labeling and cleared intended use.The instructions for use (ifu) art.# 70104.5686, common device name: ifu: quadrox-i pediatric g-134, version 04, chapter 7: application, clearly state the following: "secure all tube connections in the pressurized section of the tube system with tube ties." as the tubes needs to be connected correctly by the end user the reported failure is out of manufacturers range.Based on the received information and the investigation results obtained so far the reported failure could not be confirmed.The data is also 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.

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: 5430229
• MDR Text Key: 38701965
• Report Number: 8010762-2016-00070
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K90533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

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: 05/01/2017
• Device Model Number: VKMO 31000
• Device Catalogue Number: 701049185
• Device Lot Number: 92164546
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1