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

Model Number BEQ-HLS 7050 USA

Device Problem Infusion or Flow Problem (2964)

Patient Problem Death (1802)

Event Date 03/21/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Device requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the customer: it was reported that the cardiohelp combined with the hls set had no flow.The customer removed the hls set and used the hand crank.The customer decided to place the hls set back in the cardiohelp drive.Once the hls was set in the drive the error message "disposable error" was displayed and no flow was given.(b)(4).

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.According to the laboratory: clots can be confirmed.Leak test performed.A very severe leak in the venous sensor was detected.And documented.Creating a cycle with the cardiohelp is not necessary because the venous sensor is leaking.A further examination is currently not possible for security reasons.Corresponding measures have already been initiated.As soon as these measures the investigation can be resumed.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Added the lot # and expiration date in suspect medical device section.

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).(b)(6).

Event Description

(b)(4).

• Brand Name: HLM SET SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7440889
• MDR Text Key: 105837317
• Report Number: 8010762-2018-00140
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2018,07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2018
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Device Lot Number: 70118745
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2018
• Date Manufacturer Received: 03/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death