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

Model Number BEQ-HLS 7050 USA

Device Problems Display or Visual Feedback Problem (1184); Loose or Intermittent Connection (1371)

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

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was scrapped by the hospital; therefore no manufacturer laboratory investigation was possible.The corresponding tech support determined that a loose cable connection was most probable causing the issue with the venous pressure reading.The hls module has one cable connection for the venous pressure, arterial pressure and internal pressure reading.This leads to the conclusion if a loose / intermittent connection was leading to the failure, all 3 measurements should have been affected.Beside of this the described failure of the pven is known to maquet cardiopulmonary and is thoroughly investigated under (b)(4) with the following outcome: an investigation of oxygenators in question showed that the venous pressure sensors are probably corroded.A white crystalline substance has been found on the pins of the pressure sensor.The priming solution leads to an electrolysis when cardiohelp starts to work.The electrolysis starts instantly and causes a "short circuit" between the pins.The "short circuit" furthermore leads to implausible sensor pressure readings.The most probable root cause is that varnish applied on pcb and plugs of venous pressure sensor does not resist the etching of the saline.The root cause investigation is still pending.Based on this it could be concluded that the pven deviation most probable could also have been caused by the issue already investigated by (b)(4).This data will be handled by a designated maquet tracking and trending process.

Event Description

According to the customer: "support was initiated on (b)(6) 2016 with hls set having lot #70110733 at approximately 1600, est.The pven was intermittent in its reading/display of values (readings of 570mmhg).And it would fluctuate between positive & negative numbers, and sometimes not be displayed at all.The part and pint were functioning correctly.On (b)(6) 2016 sales rep received a call, he was told by the account the pven was not displaying its values correctly, similar to what (b)(6) noticed on thursday.(b)(4) assisted by phone (advice to reinsert the cable which they said was loose) and after, the account stated all was well with the pven.The account then transported this patient to a different hospital.The patient was put on a different (non-cardiohelp) circuit and the hls set was trashed.(b)(4).

• Brand Name: HLM TUBING 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: 5960368
• MDR Text Key: 55453569
• Report Number: 8010762-2016-00570
• 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
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Device Lot Number: 70110993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Date Device Manufactured: 04/01/2016
• 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