MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HQV 3208#ADULT PACK; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number VKMO 71000

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2015 12:08 pm (gmt-5:00) added by (b)(6) ((b)(4)): maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).A supplemental medwatch will be submitted as soon as further information becomes available.Additional information: the product mentioned under section d is a tubing set with reservoir and the included affected component has the contributing design function of the reservoir which is registered under 510(k): (b)(4).

Event Description

Customer reported that "at initiation of ecc a blood leak were visualized at the top of the venous reservoir.The leak occurred were the venous tube is connected to the reservoir, see attached pict.The surgery was interrupted and disposables were replaced." (b)(4).

Manufacturer Narrative

Visual inspection has been performed and cracks in the temperature sensor were detected.A crack at the ll of the blood inlet connector and cracks at the cap of temperature sensor.Thus the failure could be confirmed.Device history record of the complaint lot has been investigated and no abnormality was found.Moreover, no scrap record for the related material was found.As a corrective action, based on customer complaints, capa (b)(4) was opened.Within the capa, a root cause analysis (rca) was carried out, which identified three probable root causes (material failure, transport damage and method) and actions were identified for each root cause.The action for material failure is checking and verifying the specification of materials of the temperature probe and the luer lock.The action was completed on 2015-08-28 and all records of affected batches available for investigation were found to be within specification.Additionally, user handling was observed by maquet field staff at the institution, and there was no indication that there is a user handling issue at the customer site.All of the failures reported by the customer were detected during use and were not identified upon receipt; therefore there is no indication from customer complaints of damage during packaging or transit.The most probable root cause is an operation or mechanical failure during manufacture resulting from too high torque being applied as the torque values are not specified in the bops.Full further investigation and all other actions and the effectiveness thereof will be carried out as part of the capa investigation.

Event Description

(b)(4).

• Brand Name: HQV 3208#ADULT PACK
• 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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5210470
• MDR Text Key: 30713339
• Report Number: 8010762-2015-01149
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 71000
• Device Catalogue Number: 70104.3792
• Device Lot Number: 92166706
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• 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
• Patient Outcome(s): Required Intervention