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

Model Number VKMO 11000

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital:"a liquid leak is detected on the arterial line in the manifold line in the back flow part.We are handling this with the normal press line." (b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002 (b)(4).Maquet cardiopulmonary (b)(4) requested the products for manufacturer investigation.Claimed lines were investigated visually by laboratory.A leak test was performed and it was observed that the adhesive connection between the tube and the adapter was leaking for both lines.The failure was confirmed by the laboratory.Device history record review was performed and no references were found which are indicating a nonconformance of the product in question.Sap database trend search was performed (similar failure) which came to following results: (b)(4).Due to this information no systemic issue could be determined.As a corrective action, getinge cp antalya was initiated a capa, based on several complaints showing the same symptoms with different material numbers than the one in this complaint, in order to determine the root cause and initiate further actions to determine corrective measures for the failure.Although, capa (b)(4) was closed, all further steps will be performed in accordance to ecr (b)(4).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

(b)(4).

• Brand Name: VENOUS HARDSHELL CARDIOTOMY RESERVOIR
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7537214
• MDR Text Key: 109239739
• Report Number: 8010762-2018-00176
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K141432
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 11000
• Device Catalogue Number: 701049279
• Device Lot Number: 92229011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1