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); Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "no alarms were present and all readings appeared ok per the specialist however the patient was not being oxygenated sufficiently.They attempted to change the oxygen source and related tubing without success.They then changed out the circuit successfully.It was noted that there was clot observed in the circuit" (b)(4).

Manufacturer Narrative

The product was visual inspected in the laboratory of the manufacturer.During rinsing no clots were detected.A crack at the luer lock of the blood outlet cover housing was detected.An additional complaint will be opened in order to track and trend this observation.The product in question was tested for its o2 and co2 transfer rate at for its pressure drop behavior at maximum flow.According to the test report the product does not pass the o2-transfer rate test.Based on the test results the reported failure could be confirmed.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.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action.

Event Description

(b)(4).

Manufacturer Narrative

In the decontamination/complaints laboratory, all four sides of the oxygenator were sawn open, and the mats were inspected for any signs of damage, marks or any other anomalies.No anomalies were found.The therapy application manager evaluated the issue from a clinical perspective.Unfortunately, the clinical information is insufficient to determine a clear root cause.The results of the performance tests confirm to some extent an impaired gas exchange performance at high flow conditions.Although the applied flow rate at the incident site is unknown, it cannot be ruled out that high flow rates were applied.Thrombus formation has been confirmed which could be a possible root cause for impaired blood/insufficient oxygen delivery.It is unclear whether the operator had set the venous saturation low threshold to trigger an alarm on the cardiohelp.However, according to the issue reported by the customer, this is likely not to be the case, and this does not represent the root cause of the issue, but rather a device safety mitigation which might not have been utilized.Maquet cardiopulmonary has no corresponding data about the setup, flow parameters, anticoagulation protocol, the patient's medical history (especially coagulation disorders), etc.In the absence of further information, the root cause remains unclear.

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: 6129720
• MDR Text Key: 61291553
• Report Number: 8010762-2016-00687
• 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,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Device Lot Number: 70107827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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