MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

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

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The product was requested for return to the manufacturer for laboratory investigation but was not received yet.The investigation is still pending.A supplemental medwatch will be submitted after new information has been received.

Event Description

It was reported that hls set was stopped reading pressures during a support run.The device was not function properly.The set was replaced with a new.No harm to the patient was reported.After follow up with the ccp, there appears to be green residue within the cable that attaches the hls set to the cardiohelp-i console.The issue with the cable will be handled in a separate complaint ((b)(4)).(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the product for investigation on (b)(6)2019.This complaint will be closed since the requested part has not been returned for investigation despite several requests.The complaint will be re-opened if requested part or any new relevant information is received.Thus the failure could not be confirmed the ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint number:(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8678057
• MDR Text Key: 147319865
• Report Number: 8010762-2019-00162
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention