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 No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital:"recirculating line leak at the one-way valve.Customer reports it has happen on three occasions.Customer has two lines to return." (b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary gmbh requested the products for manufacturer investigation.Both of the purge lines were investigated by laboratory.During the visual inspection of the both lines, a leak was found at the adapter which was between the connection of tube 70105.2890 and tube 70104.9093.The adhesive connections of the tube and adapter were not proper.The failure was confirmed by the laboratory.Device history record of the complained lot has been investigated and no abnormality was found.Moreover, there is no non-conformality and no scar related to similar failure for the claimed materials.The root cause could be related to the gluing failure.However, the exact root cause will be determined according to the capa (b)(4).A sap trend search was performed (search for material 70105.5207) which came to following results: one additional complaint was recorded.An open search of the trackwise complaints database using the material number 70105.5207 was carried out and the searched returned no complaints.Based on the trending for material number, a systemic issue is not indicated.As a corrective action, for the previous complaints regarding to the same failure, we had opened capa (b)(4) and all actions will be followed by capa (b)(4).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 complaints.Based to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• 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: 6702472
• MDR Text Key: 79910813
• Report Number: 8010762-2017-00219
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K141432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

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: 03/20/2019
• Device Model Number: VKMO 11000
• Device Catalogue Number: 701055207
• Device Lot Number: 92222131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 09/07/2017
• Date Device Manufactured: 03/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1