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 Occlusion Within Device (1423); Pumping Stopped (1503)

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

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: circuit flowed very well for a few minutes then abruptly stopped.Had rpm`s but zero flow.We cut into circuit and back bled cannulas thinking there was clot.Both were fine.So we changed circuit emergently and found a giant clot in the venous channel partially in the pump of the hls module adherent completly occluding flow.The device has been replaced during the procedure.No harm to the patient was reported.Internal reference: (b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.According to the investigation report of our laboratory a hls module advanced 7.0 has been returned.The sample was unscrewed by the customer and demolished the trace (board).Since the original state is no longer existent, the sample on the cardiohelp can not be tested.Clots can be confirmed.Thus the failure could be confirmed.Dhr review result: affected product: basic lot 70109238 and packaging lot 70109565 (serial number (b)(4)).The avz from xqk 230 to xqk 239 (b)(4) was reviewed on (b)(6) 2017.There were no references found, which are indicating a non conformance of the product in question.Additionally a review of the weekly performance monitoring according to si-c-09 has been reviewed (b)(4),the performance tests passed the acceptance criteria.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(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: 6921809
• MDR Text Key: 90087825
• Report Number: 8010762-2017-00323
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 70102794
• Device Lot Number: 70110397
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Date Device Manufactured: 02/01/2016
• 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