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

Model Number 12210 VAK-210 KIT

Device Problems Material Frayed (1262); Physical Resistance/Sticking (4012)

Patient Problem Arrhythmia (1721)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).According to (b)(6), the complaint initiator, the defective disposable has been scrapped.Therefore it can not be investigated in the laboratory.

Event Description

According to the customer: wire frayed at needle tip when trying to adjust position of wire.Became stuck and entire wire and needle was removed urgently due to arrhythmia that subsequently resolved.Customer had to open another vak-210 kit to complete the procedure.Additional information: there were no negative consequences for the patient.(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: 7925576
• MDR Text Key: 122622774
• Report Number: 8010762-2018-00268
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12210 VAK-210 KIT
• Device Catalogue Number: 701063540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention