MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT MEDOS HILITE 7000 LT OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number F35210013

Device Problem Improper Flow or Infusion (2954)

Patient Problem Hypoxia (1918)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Of note, fresenius medical care renal therapy group, llc (fmcrtg) has assumed responsibility for reporting on us distributed medos medizintechnik ag (medos) products as per us fda requirements.This arrangement is reflected in a quality agreement between fmcrtg and medos, which was made effective on 05/15/2020.The product being reported was cleared to be marketed in the us market as of 01/09/2014.The reported event was previously captured within medos complaint handling system.

Event Description

It was reported that almost immediately after initiation of use, low po2 and high pco2 readings were observed (venous and arterial).The device was used for about an hour and at the end the fio2 was running at 100% and an arterial po2 of 132 was only able to be achieved.The product was replaced with a quadrox and an arterial po2 of 443 was immediately observed.The oxygenator was flowing 5l/min.It was reported that the device was not able to be returned because it was discarded.There was no patient impact as the patient was not adversely affected.Manufacturing records were reviewed for any irregularities to help identify any potential error after delivery of the product.Every processed component of the oxygenator has to pass a 100% incoming control before assembly.Several in-process controls and a 100% final testing including performance tests of each produced medos oxygenator will be executed.The reported oxygenator passed every required examination.All results were within the given specification.Additionally, the records from oxygenators from the same batch were reviewed.None of them were reported as showing similar abnormalities.Further investigation can not be carried out without the complaint product or without any clinical information about the product.

Manufacturer Narrative

Additional information: h10 clinical investigation: a temporal relationship exists between the inadequacy of gas exchange using the medos hilite 7000t oxygenator and the impaired oxygenation of this patient, evidenced by a lower than expected post-oxygenator abg pao2 blood saturations.It is well-established that critically ill patients undergoing ecmo are at high risk for transient thrombosis, blood loss and poor response to oxygenation.Due to the limited information obtained, the cause of the inadequacy of gas exchange cannot be determined at this time.Patient response to effective gas exchange in ecmo is largely dependent on many factors including the patient¿s injury or illness, appearance of the circuit and vascular cannulas, identification of recirculation, ecmo device settings, and inherent cardiac dysfunction.Based on the limited information, there is no specific allegation or objective evidence indicating a medos device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s serious adverse events.

• Brand Name: MEDOS HILITE 7000 LT OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 10150609
• MDR Text Key: 196267361
• Report Number: 1713747-2020-00233
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K133261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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 Expiration Date: 04/30/2019
• Device Catalogue Number: F35210013
• Device Lot Number: 20160406M112
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention