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 01/25/2021

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 event occurred during the early hours of january 25. I started using the oxygenator at 23 on 24 and stopped working at approximately 1 in the morning on january 25. At that time the arterial blood gas values were po2: 62. 7 and pco2: 51. 2. I raised fio2 to the maximum and changed the gas line in case the filter had clogged, i checked all the connections and i continued with poor oxygenation. I mentioned it to the surgeons, the anesthesia team helped me by ventilating with the respirator and we left cec. I took the opportunity to change the oxygenator because we had to re-enter cec quickly, and the latter was perfect, which had the same batch. 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: 11274171
• MDR Text Key: 245318521
• Report Number: 8010762-2021-00094
• 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: 02/03/2021
• 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