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

Model Number HLS SET

Device Problems False Reading From Device Non-Compliance (1228); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Maquet cardiopulmonary (b)(4) requested additional information regarding this complaint but none was received until yet. Investigation is still pending. A supplemental medwatch will be submitted as soon as further information becomes available. Additional information: the product mentioned under 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

Description from the customer report: "customer claimed that the part was reading a negative number while flowing forward. Rpm's were approximately 2600, flow was 1. 8 lpm, pven was -212, and p-art was -38. Prior to calling the maquet support line customer had turned down the rpm's and clamped the arterial and venous lines and re-zeroed the pressure transducers on the cardiohelp. There also was concern by the account that the avalon cannula could be out of position. The patient was being supported sufficiently through this call and the account was going to check cannula position in the morning. Local ptm notified. " (b)(4).

Manufacturer Narrative

Additional information has been evaluated with the internal therapy application manager. Based on that the reported erroneous arterial pressures were due to the fact that the cannula needs to be repositioned. As the cannula has been repositioned the pressure readings got normal and the problem was solved. Based on the received information no failure of the hls set occurred and therefore no investigation is needed. Due to this complaint # (b)(4) is closed. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary. Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4). Additional information received on 09/07/2016: "customer said that the hls set was showing negative values due to the fact that the cannula was in the hepatic vein and needed to be repositioned. Once the surgeon repositioned the cannula the pressure readings on the hls set normalized and was functioning correctly. They kept the patient on the hls set for 72 hours and then weaned him successfully off. ".

• Brand Name: HLM TUBING SET
• Type of Device: OXYGENATOR, 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: 5890785
• MDR Text Key: 53596750
• Report Number: 8010762-2016-00532
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: HLS SET
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial