MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number VKMO 1100

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: "there is blood leakage from the connection of the sampling manifold during patient use." (b)(4).

Manufacturer Narrative

According to the complaint report the product was not available for investigation.Therefore no laboratory investigation could be performed in the laboratory of manufacturer.Although the product was not available, the investigation was performed based on received picture.It could be clearly seen that there is a blood leakage between 70104.5749 rot-nodop tube & 70105.2890 adapter tube.Failure could be confirmed.Trend search was performed for sap&trackwise systems and 8 additional complaints were found.Based on the last 12 months sales figures no systemic issue was determined.Getinge cp antalya is aware of the issue and due to this capa 2015/03 has been already initiated in order to determine the root cause and take corrective / preventive actions.The adapter with the article number 70105.2890 is already involved in capa (b)(4).A new material/reducer was supplied and the new material will be used instead of this adapter in the scope of capa (b)(4).The red tube will be assembled with the reducer to solve the problem.There is ecr 18011002 regarding to these changes.This lot was manufactured before the corrective actions are implemented.The most probable cause of the failure is found as material failure.The data is also being handled through a designated maquet cardiopulmonary 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.This complaint is closed.

Event Description

Ref.: #(b)(4).

• Brand Name: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• 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: 7079109
• MDR Text Key: 93768317
• Report Number: 8010762-2017-00377
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141432
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2019
• Device Model Number: VKMO 1100
• Device Catalogue Number: 701049279
• Device Lot Number: 92229009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Date Device Manufactured: 07/01/2017
• 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