MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number HQV 1806-1

Device Problem Improper Flow or Infusion (2954)

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

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: after a long period of proper function at a flow of 7 l/min and o2 of 400 ml the customer was observing that no oxygenation occured.The patient impended to decarboxylate.After exchange of the product, no further incidents were observed.(b)(4).

Manufacturer Narrative

The product was investigated visually in the (b)(4) of the manufacturer.No clotting was detected during optical observation as well as during rinsing of the product's inner life with water.The laboratory test report is providing the following results: the product in question has successfully passed the o2 / co2 and pressure drop performance test.The measuring results of the performance test are in range.Based on this the cause of the failure was determined to not be attributed to a device related malfunction.Based on the results and information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.Thus the failure could not be confirmed.Dhr review: during the review of the avz no production parameters could be identified that would indicate a nonconformance during production, in regards to the reported failure.A sap search was performed for p/n 70104.2971 / failure code 0306 oxygenation with the following result: 1 additional complaint was found out of (b)(6) 2016.Due to this information no systemic issue could be determined.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 no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/SOFTLINE COATING
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 5751811
• MDR Text Key: 48248427
• Report Number: 8010762-2016-00408
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HQV 1806-1
• Device Catalogue Number: 70104.2971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 29 MO