MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ HLS 7050

Device Problem Device Inoperable (1663)

Patient Problem Thrombus (2101)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

On 09/03/2015 (b)(4).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device (b)(4).The device has not been returned for investigation.A supplemental medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.

Event Description

Two small areas of thrombus were identified on the 2 lateral edges on the blood outlet side of the quadrox-id oxygenator.Clinical decision was made not to exchange the device as the device was functioning properly.Additional inf received aug 31,2015: as of late friday afternoon (b)(6) 2015, the hls disposable was still being utilized without issues.

• Brand Name: HLM TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5053894
• MDR Text Key: 24943878
• Report Number: 8010762-2015-01028
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ HLS 7050
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70091076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2015
• Date Manufacturer Received: 08/10/2015
• 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): Required Intervention