MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701044054

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the customer: it was reported that the perfusionist had an allergic reaction to clorina.Additional information: the incident occurred during maintenance/service.(b)(4).

• Brand Name: MAQUET HCU40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, 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: 8037850
• MDR Text Key: 126105226
• Report Number: 8010762-2018-00293
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130300
• 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
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 701044054
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2016
• 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
• Patient Outcome(s): Other