MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 71000-USA

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 04:10 pm (gmt-4:00) 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).The device has been requested for evaluation; but has not been received.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

It was reported that during setup, it was noted the arterial outlet had broken off the device.The corner of the box was noted to be damaged and taped.No patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).During laboratory investigation of the manufacturer a visual inspection was performed.Thereby a broken blood inlet connector could be confirmed.During visual inspection a damage at the packaging was detected.This damage was on the same side/position like the blood inlet connector.It was noticed that the packaging was taped in the inside of the package with maquet tape.A possible cause could be determined as a packaging failure.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: HLM TUBING SET W/SOFTLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5111879
• MDR Text Key: 27182742
• Report Number: 8010762-2015-01070
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K090533
• 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: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: VKMO 71000-USA
• Device Catalogue Number: 70106.4568
• Device Lot Number: 92143679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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