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

Model Number VKMO 11000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/09/2018

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 one-way valve connection during patient use." (b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).The received picture clearly shows that there was leakage between the no-dop tube 70104.5749 and adapter tube 70105.2890.Sap trend search was performed (material 70104.9279, failure code 0128) which came to following results: 7 additional complaints were recorded in last 12 months which appears reported issues are the same.Based on the sales figures of the last 12 months following occurrence rate has been calculated: (b)(4), which is below 1%.Due to this no information no systemic issue could be determined.Maquet cardiopulmonary (b)(4) is aware of similar incidents with different material numbers and failure codes.Device history record was reviewed.There were no references found which are indicating a non conformance of the product in question.As a corrective action, capa (b)(4) has been already initiated to address the appropriate corrective/preventive actions.The adapter with the article number 70105.2890 line 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).Based on this complaint could be confirmed.The data is also 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: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7189333
• MDR Text Key: 97867499
• Report Number: 8010762-2018-00016
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2019
• Device Model Number: VKMO 11000
• Device Catalogue Number: 701049279
• Device Lot Number: 92232921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1