MAUDE Adverse Event Report: JULIA KAPFENBERGER HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

Device Problem Device Sensing Problem (2917)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that the disposable oxygenator had problems reading pressures over the weekend.The customer attempted to re-zero the pressures and change out the pressure cord but they didn¿t get any better.They stated that this was a covid patient and the hls would not be returning.Complaint id: (b)(4).

Manufacturer Narrative

The investigation of the manufacturer is ongoing.(b)(4).

Manufacturer Narrative

The reported event occurred in usa.The following complaint information was provided to maquet cardiopulmonary: "the following disposable had problems reading pressures over the weekend.We attempted to re-zero the pressures and change out the pressure cord but they didn¿t get any better.The occurrence happened with the following disposable lot 30002040458 on the following cardiohelp ( 90410351).They stated that this was a covid patient and the hls would not be returning.The product was exchanged, all pressures were fine after they changed out the hls set." no harm was reported.The affected product was not available for technical laboratory investigation of the manufacturer.Thus it was not possible to determine the exact root cause of the reported failure.Despite several attempts no information about which pressures were affected exactly and which values were measured was provided.Additionaly the customer did not provide the correct lot # of the product.The lot # provided is invalid and was not traceable in our system.Thus it was not possible to perform a dhr review.However, the reported failure "problems reading pressures" can be linked to the following most probable cause according to our risk management file: -wrong pressure measurement due to malfunction of the pressure sensor based on the investigation results it was not possible to confirm the reported failure "problems reading pressures".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.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 14797264
• MDR Text Key: 301178370
• Report Number: 8010762-2022-00243
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1