MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Component Missing (2306)

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

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The affected hls set is requested for further investigation in the getinge laboratory but not received yet.A follow up medwatch will be submitted when additional information becomes available.

Event Description

Event occurred in the us.Customer states that an hls set was opened and a patient was placed on support, however, when the disposable was removed from the packaging, it was noted that the cap for the dialysis lock and valve connector, on the hls disposable was missing.Customer used the hls set for treatment.No other issues noted.No indication of actual or potential for harm or death has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "dialysis lock and valve cap is missing" was noticed by the customer when the disposable was removed from the packaging.Customer used the hls set for treatment.No other issues noted.It was the only remaining kit for the treatment.The affected product was requested for further investigation but the hls set was disposed by the customer therefore a technical investigation could not be performed.A review of the complaint data for similar complaints was performed but no confirmed complaint with a potential root cause was found.A device history review (dhr) was performed for the affected hls module and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Production related influences can be excluded.No potential root cause could be determined.Based on these investigation results and the provided information by the customer, the reported failure "missing dialysis lock and valve cap" cannot be confirmed.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 D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11485835
• MDR Text Key: 239818620
• Report Number: 8010762-2021-00189
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Patient Sequence Number: 1