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

Model Number HQV 103800

Device Problem Occlusion Within Device (1423)

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

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted if additional 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-i which is registered under 510(k): k082117.

Event Description

The customer reported an oxygenator occlusion.The product was changed out.No further information was provided by now.(b)(4).

Manufacturer Narrative

The oxygenator was received full of blood.When the oxygenator was flushed, very small clots were washed out.The filter of the oxygenator was found to be heavily occluded with clots.It was cleaned twice with sodium hypochlorite, and then was sent to the performance laboratory to for further testing.The results of the tests showed that the gas exchange and delta p performance were not within the specified range.The measurement of the pressure drop (delta p) was not possible because of clotting.However, as the customer stated that no further information would be available from this case, including details of patient condition before and during the reported incident, the anti-coagulation measures in use, and any other clinical or application-related factors that may have caused or contributed to the incident, the application therapy manager concluded that there is insufficient information available to carry out a meaningful clinical assessment.Therefore it has not been and will not be possible to establish a definitive root cause for the observed clotting.A device history record of the affected lot has been investigated and no abnormality was found.This complaint is the only complaint related to the product group 10000.A product/manufacturing-related malfunction is not indicated.Investigation of this complaint and trending for this issue indicates that this is an isolated case, for which maquet cannot get any further information.Based on the investigation results, no further investigation or action is possible and the complaint will be closed.

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: 5669732
• MDR Text Key: 45918144
• Report Number: 8010762-2016-00346
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082117
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• 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: HQV 103800
• Device Catalogue Number: 701066470
• Device Lot Number: 92182275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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