MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BO-VKMO 70000- JAPAN; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number 701064582

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).A follow-up medwatch will be submitted if additional information becomes available.The product mentioned is a tubing set with reservoir and the included affected component has the contributing design function of the reservoir which is registered.(b)(4).

Event Description

It has been stated that during priming for regulary surgery, it was observed that blue foreign matter was inside of the venous reservoir.The customer replaced the whole circuit and finished the surgery without any problem.No adverse effects on the patient.(b)(4).

Manufacturer Narrative

The 70106.4557 bo-02971-j#reservoir vhk 71000 softline.(lot# 92178043) has been received for further investigation in our laboratory.It has been investigated as follows: visual inspection of the reservoir.Result: during visual inspection of the reservoir it has been detected that one of 5 welding points, which are connecting the cover of the reservoir with its filter basket, is broken.During priming those broken welding point was rinsed into the tube and represents therefore the complained blue foreign matter.Thus the failure could be confirmed.An supplier (b)(4) complaint has been initiated.Investigation result: the most probable root cause could be determinded as transportation failure.Supplier investigated as follows: during the production the welding process of pins has been observed.The welding machine runs automatically.The temperature and the time have been automatically entered to the machine.During production of reservoir, all the stages have been controlled visually and there were no possibility that there could be any broken pieces in the reservoir.Since high pressure air has been pumped to the reservoir after each process.In order to realize the failure, the products have been tested by throwing them in different ways.It was observed that the pins (blue spots) were broken similar to the complaint.Additionally, process risk assessment of the welding parameters have been reviewed.Therefore, based on the investigation, it could be possible that the pins were broken off during transportation.The operators have been informed with regards of the complaint.Device history record of the complained lot has been investigated by (b)(4) and no abnormality was found.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.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: BO-VKMO 70000- JAPAN
• 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: 5596907
• MDR Text Key: 44141968
• Report Number: 8010762-2016-00281
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102919
• 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: 04/06/2016

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: 07/01/2017
• Device Model Number: 701064582
• Device Lot Number: 92178043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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