MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

Patient supported on 5.0 hls set.Post mo po2 falling below 100 on 100% fio2.Customer increased sweep flow to blow out condensation without success.Patient is stable and physician will attempt to continue to support the patient with current hls until a change is clinically deemed necessary based on patient presentation.Complaint (b)(4).

Manufacturer Narrative

The reported failure was that the post mo po2 falling below 100 on 100% fio2.As statd by the ssu on (b)(6) 2020 via communication field the perfusionist removed the disk filter connected to the green sweep-gas line and the problem resolved.The patient was weaned off without harm.The disposable was put in the trash and therefore not available for further investigation.No further concern from the customer or need to follow up.According to the communication with the ssu dated on (b)(6) 2020.The most probable root cause could be determined that the gas line filter was either clogged or cracked.Thus the reported failure could be confirmed.The hls set was directly involved in the incident which occurred during patient treatment.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 # (b)(4).

• Brand Name: TUBING SETS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9915285
• MDR Text Key: 187915911
• Report Number: 8010762-2020-00124
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0
• Device Catalogue Number: 70105.2797
• Device Lot Number: 70137583
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1