MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VENOUS BUBBLE TRAP (VBT); DEFOAMER, CARDIOPULMONARY BYPASS

Model Number BE-VBT 160

Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested the product back for investigation and received it on 06/24/2016.Device history record of the complained lot has been reviewed by maquet cardiopulmonary (b)(4).Thereby no abnormality was found for the related material.All the controls were done according to the process control form, also, it was controlled that the leakage test in the vbt production was performed.A supplemental medwatch will be submitted when further information becomes available.

Event Description

Description from the customer report: "not able to suck the collected air on top of the venous bubble trap on the usual way.They finally managed to do this manually with a syringe" (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product back for investigation and received it on 06/24/2016.Our customers need to fill out a declaration of infection risk.If this document is not received we are not able to investigate the product.In case # (b)(4) the hospital did not fill out the declaration of infection risk completely due to given law in the (b)(6) they are not allowed to fill out a section.Therefore, the sample could not investigated by our laboratory.On the other hand, device history record of the complained lot has been reviewed by maquet cardiopulmonary (b)(4) and no abnormality was found for the related material.All the controls were done according to the process control form, also, it was controlled that the leakage test in the vbt production was performed.A sap trend search has been performed (search for material and component number 70103.0118, error message: 1000) which came to following result: no additional complaint were recorded.Based on this, a confirmation of the failure based on previous complaints is not possible, and there is no systemic issue indicated.

Event Description

(b)(4).

• Brand Name: VENOUS BUBBLE TRAP (VBT)
• Type of Device: DEFOAMER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5755937
• MDR Text Key: 48362044
• Report Number: 8010762-2016-00413
• Device Sequence Number: 1
• Product Code: DTP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K082412
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: BE-VBT 160
• Device Catalogue Number: 70103.0118
• Device Lot Number: 92187089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2015
• 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