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

Model Number HLS 7050NS USA

Device Problem No Display/Image (1183)

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

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2016 01:22 pm (gmt-5:00) added by (b)(6) ((b)(4)): maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).Maquet (b)(4) requested the product back for investigation but has not received the device.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.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)(4).

Event Description

It was reported that during training the customer observed that when the sensor cable was plugged into the connection for integrated sensors, neither the part, pven, pint or tart were displayed.A different red hls was then cut into the existing non-sterile set and the before-mentioned values were displayed and training was continued.The red hls in question was then placed on another cardiohelp machine and the same phenomenon of no pressures or arterial temperature was observed.Product is marked non sterile.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product for manufacturer's laboratory investigation.During visual inspection small particle at the plug of the hls module were found.Furthermore it has been found that the sensor on blood outlet connector (arterial side) has been corroded.It seems as if the plug and the sensor got wet with priming fluid.Before cleaning the product the plug was sealed.Therefore no fluid was able to get inside.Hls module was flushed and dried.Afterwards the product has been connected to the cardiohelp.All values and signals were shown.Based on the investigation results the responsible nc owner of nc-15-02-173 has been contacted.The reported and investigated failure is not related to nc-15-02-173.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

(b)(4).

Manufacturer Narrative

As the product in question was used only for training, and is clearly labeled that it must not be used for patient/human use, and that it can therefore never be used on patients, the complaint has been re-evaluated not to require further investigation.The device is used under conditions in a training environment that are outside those that are normal and expected.The incident was initially evaluated to be a reportable event.However, it should be noted that under current internal processes and external regulations, the reported failure does not constitute a customer complaint, and therefore should have been evaluated to be not reportable.This final report is being used to communicate this correction, hence no codes have been entered.Based on the information available and the investigation results obtained, the reported failure could be confirmed.However, as this issue does not constitute a customer complaint, as confirmed by the perfusion territory manager who did not require an investigation, further investigation is not warranted, and the complaint will be closed.

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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5399520
• MDR Text Key: 37621175
• Report Number: 8010762-2016-00053
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: HLS 7050NS USA
• Device Catalogue Number: 701054325
• Device Lot Number: 70106715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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