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

Model Number HQV 98701

Device Problems Air Leak (1008); Loose or Intermittent Connection (1371)

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

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it until yet.A device history record has been performed by maquet cardiopulmonary (b)(4).Thereby no abnormality was found.Additionally 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.

Event Description

"unexplained appearance of air after de-airing the oxygenator.After analysing the issue, it was noticed that the 3-way stopcock provided within the set let the air enter and are not tight.The 3-way stopcock of the set were replaced by 3-way stopcock from another manufacturer referenced by the hospital.No clinical consequence was reported." (b)(4).

Manufacturer Narrative

(b)(6) 2016 10:51 am (gmt-4:00) added by (b)(6) ((b)(4)): a device history record has been performed by maquet (b)(4).Thereby, no abnormality was found.Additionally no scrap record for the related material was found.The complaint statistic was conducted for complaint #(b)(4), there are no other customer complaints related to the mentioned lot number 92159851.Moreover a complaint statistic was conducted on the basis of article number (b)(4) to see if the similar problem was observed in another lot.The statistic revealed that there are no customer complaints for the mentioned product.Maquet (b)(4) will not be able to investigate the product as the product has already been discarded by the hospital.A review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.Based on this a confirmation of the failure is not possible.The data is also being handled through a designated maquet (b)(4) trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(6) 2016 10:44 am (gmt-4:00) added by (b)(6) ((b)(4)): (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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5290380
• MDR Text Key: 33323127
• Report Number: 8010762-2015-01235
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090533
• 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: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: HQV 98701
• Device Catalogue Number: 70106.3467
• Device Lot Number: 92159851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2016
• Date Device Manufactured: 03/01/2015
• 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
• Patient Outcome(s): Required Intervention