MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HQV 128702#PACK VKMO 71000

Device Problem Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up mdr will be submitted when further information becomes available.

Event Description

Description sent by the perfusionist: "the failure occurred 100 minutes after cec, when we were finished and we were going to start the pump output, so there has been no problem with the patient, since we left quickly, and the patient has woken up and evolved without problems today. Male, (b)(6) years old, weight (b)(6), size 1. 67cm, bsa 1. 99m2. It was at a pump flow of 3800, with 32 degrees of temperature, with a flow of gases of 1. 2 and a fio2 of 50% and the gasometry was: ph7. 32, po2 156, pco2 42, and so2 98. 7%. Suddenly the blood became very dark and i took out others, having previously risen, the gas flow to 3l and the fio2 to 60%, and the result was: ph 7. 26, po2 51. 7, pco2 53. 3, so2 84. 4%. I went back up to fio2 of 100% and 4l and i left cec. " complaint: (b)(4).

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; kehler strasse 31; hechingen 76437 ; GM 76437
• Manufacturer Contact: neue rottenburger strasse 37; kehler strasse 31; hechingen 76437 ; 4972229321
• MDR Report Key: 11284121
• MDR Text Key: 242862241
• Report Number: 8010762-2021-00098
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K132829
• 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: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/03/2022
• Device Model Number: HQV 128702#PACK VKMO 71000
• Device Catalogue Number: 70107.4266
• Device Lot Number: 92297607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage