MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number H 4506-1

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

Feb.19, 2016 11:12 am (gmt-5:00) added by (b)(6): (b)(4).Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it.A review of the device history record for the lot has been reviewed by maquet cardiopulmonary (b)(4).No scrap record for the related material was found.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k053025.

Event Description

Feb.19, 2016 11:05 am (gmt-5:00) added by (b)(6): description from the customer report (b)(6): on the priming line of the complete set, the blue cap became loose on a view set.It seems that the filter had only been pinned and not glued.(b)(4).

Manufacturer Narrative

The complaint has been investigated by maquet (b)(4).Thereby the most probable cause has been determined as a material failure.The device history record has been reviewed and no abnormality was found.The samples related with the failure were forwarded to the supplier ((b)(4)) and investigated in the laboratory.Based on the information given by the supplier, the failure could be happened during the transport, storage or sterilization of the component, which made the retaining force of the filter really weaker.The physical explanation is: the filter is kept in its seat by the elastic deformation of the filter raw material (polypropylene).If the material is stored at high temperature (or sterilized at too high temperature) the polypropylene becomes softer and achieves the shape of the seat, so the elastic deformation is strongly reduced and consequently the retaining force decreases.On the other hand, the storage and sterilization conditions are automated and monitored, therefore maquet (b)(4) does not think that this could have an influence.As far as transportation is concerned trucks are monitored with dataloggers at the hottest season (defined temperature is 10°c - 30°c).If there was an influence of transportation, all of the pieces could be affected.Maquet (b)(4).Will continue to monitor the trend in their production.Furthermore as a corrective action the operators were informed and trained regarding the complaint.Investigation is still pending.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET
• Type of Device: OXYGENATOR, 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: 5449094
• MDR Text Key: 39118140
• Report Number: 8010762-2016-00101
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Model Number: H 4506-1
• Device Catalogue Number: 701033845
• Device Lot Number: 92167720
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Date Device Manufactured: 08/01/2015
• 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