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

Model Number VHK 31000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested but not yet received.The investigation is pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

"the customer found the blood leakage from the middle of the blue sampling line.The customer kept using the same device and finished the procedure.No adverse effect to the patient.Incident occurred during patient use." (b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) received the product for investigation.Delivered product (70104.5813/01481 # pvc blue-nodop hose) was examined in the laboratory of manufacturer.Nodop tube blue was disinfected and cleaned with sodium hypochloride.After drying, a visual inspection and a leak test were carried out with water on the hose.A damage (cracks, cuts) was detected after 30 cm from the beginning of the tube.A leak test with water was used to confirm the leak on the hose.Based on this failure could be confirmed.A sap trend search was performed for material 70105.4166, failure code 0114 leakage at tube set components and no additional complaint was found.Due to this information no systemic issue could be determined.The most probable cause of the failure is unknown at this time.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.

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
• 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: 6741191
• MDR Text Key: 81244157
• Report Number: 8010762-2017-00245
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2018
• Device Model Number: VHK 31000
• Device Catalogue Number: 701054166
• Device Lot Number: 92206675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Date Device Manufactured: 06/01/2016
• 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