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

Model Number BEQ-015703112

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(6).Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it.Investigation is still pending.Additional information: the product mentioned under section d is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): (b)(6).

Event Description

It was reported the customer plugged in the pressure cable on their cardiohelp unit.The venous pressure displayed --- on the screen.Arterial pressure and internal pressure, as well as, the arterial temperature were displayed with normal values.Cable was unplugged and re-plugged in, but this did not resolve the issue.Cable was swapped with other cardiohelp hardware and this did not resolve the issue.Incident occurred during priming.(b)(4).

Manufacturer Narrative

Attempts for the sample to be returned were made but the sample was not received and therefore it was not possible for a full investigation to be performed.It was established that the article/material number was in fact 70105.4379 for beq-015703112#hls module, and not 70105.2794 for beq-hls 7050 usa#hls set.The issue was initially considered to be consistent with the issue investigated in (b)(4), but as the product was not available for investigation, it has not been possible to establish a definitive root cause, and the issue will not be related to (b)(4) with the currently available information.A dhr review of lot 70105475 was performed and the investigation found no abnormalities and all the controls were completed in accordance to the process control form.A search of the complaint handling database was also carried out on 2017-03-09 and no similar complaints were found matching the customer's reported issue.Based on the available information, a root cause cannot be determined.No health risk or patient impact has been identified.No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and 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 or action is warranted at this time and the complaint will be closed.This is the final report.

Event Description

(b)(4).

• 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: 5450610
• MDR Text Key: 39260702
• Report Number: 8010762-2016-00095
• 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: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-015703112
• Device Catalogue Number: 701054379
• Device Lot Number: 70105475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/13/2017
• 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