MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CATHETER, CANNULA AND TUBING, VASCULAR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BO-HQV 67302

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital: 'in custom tubing pack in plegia set, plegiox heat exchanger did not cool.Hcu was set to 3 celsius and the outgoing plegia was measured at first 12 celsius and a bit later it was 15 celsius.Procedure was completed without changing the plegiox.' (b)(4).

Manufacturer Narrative

The sample in questions has been sent to (b)(4) for investigation.Sample has been unpacked and visually inspected.No abnormalities were found during this inspection.For further investigation the sample has been forwarded to qa lab where it will be investigated under (b)(4).The most possible root cause will be determined in (b)(4).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.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

(b)(4).

• Brand Name: CATHETER, CANNULA AND TUBING, VASCULAR
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 6412846
• MDR Text Key: 70430909
• Report Number: 8010762-2017-00091
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

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: 07/24/2018
• Device Model Number: BO-HQV 67302
• Device Catalogue Number: 701070505
• Device Lot Number: 92194897
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 11/30/2017
• Date Device Manufactured: 07/01/2016
• 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