MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number VKMO 11000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 12/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "there was blood leakage from the tubing of the sampling mainfold during patient use." (b)(4).

Manufacturer Narrative

08/25/2017 (b)(4): maquet cardiopulmonary gmbh requested the product for manufacturer investigation.A purge line was sent back to laboratory.No failure was detected during visual inspection.A leak test with methylene blue was performed.No leakage was detected at the connections similar to the complaint.The failure was not confirmed by laboratory.Device history record of the complained lot 92171756 has been reviewed and no abnormality was found related to the claimed material.There is a rework record related to the damaged box.Also, there is no non-conformality and no scar related to the claimed material.A sap trend search has been performed (search for material 70104.9279 and issue:0114 leak in the membrane) which came to following results: 8 additional complaint was recorded.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation 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 investigation initiations will be completed at this time.

Event Description

Ref.:(b)(4), customer ref.:(b)(6).

• Brand Name: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• 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: 6296809
• MDR Text Key: 66618870
• Report Number: 8010762-2017-00030
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141432
• 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: 08/25/2017

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: 04/01/2017
• Device Model Number: VKMO 11000
• Device Catalogue Number: 701049279
• Device Lot Number: 92171756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: 01/09/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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