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

Model Number BO-H 46700

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "during the procedure the protective cap that covers the hole in the spike connected to the cardioplegia (article (b)(4)) fall apart generating a leakage in the line." (b)(4).

Manufacturer Narrative

(b)(4).The product (item number 70102.8073) was delivered and then, it was investigated by laboratory.The blue cap did not fall down from the spike itself, a small amount of force was required to remove it.Also, the diameters of the spike and cap have been controlled and all the datas were within spec values.Therefore, the failure was not confirmed by laboratory.The affected piece part is not manufactured by mcp.Device history record of the complained lot has been investigated and no abnormality was found.A review for similar complaints was performed.An internal clinical assessment has been performed based on the received similar complaint report.It seems that this incident has not been a user error but rather a failure of the spike.Summarized it could be added that this case is not as critical assessed.A sap trend search has been performed (search for material 70105.1993 and issue: 1015 falling off parts) which came to following results: 3 additional complaints were recorded.

Event Description

Ref.: # (b)(4).

• Brand Name: HLM TUBING SET W/SOFTLINE COATING
• 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: 6198357
• MDR Text Key: 63547820
• Report Number: 8010762-2016-00733
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K090533
• 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: 07/25/2017

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: 12/22/2017
• Device Model Number: BO-H 46700
• Device Catalogue Number: 701051993
• Device Lot Number: 92179785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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