MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID SMALL ADULT/ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMOD 70000-USA

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2022

Event Type  malfunction  

Event Description

It was reported that a quadrox oxygenator was leaking water from the heater cooler out the gas exhaust port.It was on a patient for less than an hour when this happened.It was post double lung transplant patient on v-v (veno venous) support.Patient is hep c positive.The customer changed out the oxygenator.(b)(4).

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Manufacturer Narrative

It was reported that a quadrox oxygenator was leaking water from the heater cooler out the gas exhaust port.It was on a patient for less than an hour when this happened.It was post double lung transplant patient on v-v (veno venous) support.Patient is hep c positive.The customer changed out the oxygenator.There was no color change to water it was all clear.No consequences to the patient except for the need to change out the quadrox." no harm was reported.No picture of the leakage was provided.As the product was not available for technical investigation a laboratory investigation was not possible.Thus it was not possible to determine the exact root cause of the reported event.The production records of the affected oxygenator (3000168944, 3000168434) were reviewed.Following steps are performed with a 100 % inspection: tightness check blood side.Tightness check water side.According to the final test results, the oxygenator with the serial# 1947 passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the investigation results the reported failure "water leakage gas exhaust port" could not be confirmed.However,according to our risk management file the reported failure most probable was associated with a crack in thermoplastic polyurethane (tpu) heat exchange fiber.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending h3 other text : 4114.

Event Description

Complaint id: (b)(4).

• Brand Name: QUADROX-ID SMALL ADULT/ADULT
• 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; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 14432767
• MDR Text Key: 300307142
• Report Number: 8010762-2022-00176
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HMOD 70000-USA
• Device Catalogue Number: 701067840
• Device Lot Number: 3000168944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1