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

Model Number HQV 84002

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2016

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

A supplemental medwatch will be submitted after receipt of additional information.

Event Description

Customer reported that "the reservoir has a hole in it.Noticed during the case.They changed the bag.Case completed with no patient issues.(b)(4).

Manufacturer Narrative

Lab investigation has been performed: the reservoir bag has been cleaned and investigated.The visual inspection showed the hole in the connection part of the tubing.The connection between tubing and bag has a damage.Thus the failure could be confirmed.An exact root cause could not be determined and a supplier complaint has been initiated.The bag in question is not produced by maquet, so another supplier complaint has been initiated.Mcp tr has reviewed device history record of the complained lot.It has been investigated and no abnormality was found.Moreover no scrap was found for the related material.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 SOFTLINE COATED
• 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: 5773029
• MDR Text Key: 49660149
• Report Number: 8010762-2016-00427
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2016

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: 09/01/2017
• Device Model Number: HQV 84002
• Device Catalogue Number: 70105.2876
• Device Lot Number: 92178713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/08/2016; 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1