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 Clumping in Device or Device Ingredient (1095); Improper Flow or Infusion (2954)

Patient Problems Pneumonia (2011); Respiratory Failure (2484)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted if additional information becomes available.The device has been requested but not received.(b)(4).

Event Description

According to the customer: on (b)(6) 2017 around 11:50 am.(b)(6) female severe ards with hypoxemic respiratory failure secondary to influenza pneumonia complicated by pneumococcal pneumonia and bacteremia.Developed purpura fulminans.Pt was initiated on vv ecmo support 1/3 at 12:50 (31 fr avalon).Pt was not anticoagulated due to fib >1000.Elevated inr, pt, aptt.Nursing called me to the bedside due to sudden drop in flow.Shortly before this crrt machine clotted.Hls set was removed due to clotting.(b)(4).

Manufacturer Narrative

The product was returned and investigated in the laboratory of the manufacturer.A visual inspection was performed.At the blood inlet and blood outlet side no clots were visible.The hls module was cleaned with sodium hypochlorite solution.The hls module was connected to the cardiohelp device and the pressure values shows no abnormalities.No other abnormalities were detected.Thus the reported failure could not be confirmed.Based on the results obtained during investigation at this time the cause of the reported incident was determined to not be attributed to a device related malfunction.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.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: 7203036
• MDR Text Key: 97667207
• Report Number: 8010762-2018-00025
• 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: 01/04/2018,01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2019
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Device Lot Number: 70116943
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/01/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2018
• Date Manufacturer Received: 03/01/2018
• Date Device Manufactured: 02/01/2017
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR