MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number HQV 3900#ADULT PERF

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

Issue with maquet set today in that the one way valve on the red sucker was leaking, as a result i had to chop out the valve to stop this problem and there was around 50-100 mls of blood loss for the patient.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer: maquet medical systems usa, 45 barbour pond drive, wayne, nj 07470.Contact person: (b)(4).Sap trend search was performed based on (failure code 0114 leakage/ other set tube component) which came to following results: 6 additional complaints were recorded which appears reported issues are the same since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate was calculated: 0.14%, which is below 1%.Due to this information no systemic issue could be determined.Maquet cardiopulmonary gmbh requested the product for investigation.The function of the claimed valve was checked with water.When the correct flow direction was provided, the water flows through the valve without leaking to the top of the cap.Also, the function of valve was checked with water in the wrong direction.It immediately leaked at the top of the cap.Since the valve was cut out of the line by the customer, it is not possible to determine whether it was installed correctly.Based on this, complaint could not be confirmed.Valve works within specifications.Device history record was reviewed.There were no references found which are indicating a nonconformance of the product in question.The data is 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

Ref.: #: (b)(4).Customer ref.: na.

• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8150502
• MDR Text Key: 130034620
• Report Number: 8010762-2018-00323
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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 Expiration Date: 12/12/2019
• Device Model Number: HQV 3900#ADULT PERF
• Device Catalogue Number: 70105.3616
• Device Lot Number: 92233978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention