MAUDE Adverse Event Report: VENOUS HARDSHELL CARDIOTOMY RESERVOIR; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number VHK RESERVOIR

Device Problems Leak/Splash (1354); Lack of Maintenance Documentation or Guidelines (2971)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

''liva nova 1/4 inch pvc tubing slips off cardiotomy inlets.Customers have to ziptie to secure but still slides off.100mls of blood from the patient has been leaking/lost because the tubing falls off.It does not have a noticable ridge on the connection.The barbs are not rigged enough and are different to the oxy's outlet.They do not have this problem with other vendors.'' complaint # (b)(4).

Event Description

Complaint: #(b)(4).

Manufacturer Narrative

The sample could not be investigated in the maquet cardiopulmonary gmbh laboratory since the sample was scrapped by the customer.No similar complaint investigation was found to verify the failure.The investigation was conducted based on the complaint picture and information received from ssu.In the photo, it is seen that the reservoir inlet connection that the customer has assembled was secured with the cable tie.Trend search was performed for a similar failure product vkmo/vhk for the last 12 months and no systemic issue could be determined.Device history record for lot 92268315 was reviewed.There is no evidence indicating non-conformance or deviations of the product in question during the manufacturing and final release of this specific lot.According to basic operation proceudure 9203406 rev.02, there is %100 visual control of the reservoirs with/without caps.(air bubbles, black dots, stains, scratches, cracks, particles and burrs).Therefore no manufacturing problem was detected.The issue was escalated to the research &development department for further investigation.The received information regarding the tube properties which was used by the customer was shared with life cycle engineer.It was determined that the tube properties were appropriate.Also, the customer has confirmed that the perfusionist did not push the tubing all the way past the first barb.As a result of this information, the probable root cause was defined as user error.Therefore the failure could not be confirmed.Risk evaluation request was initiated to evaluate the risk and to assess whether there are sufficient instructions for the customer in the instruction for use.It seems that the customer is confused by the design difference compared to the common ¿barb¿ connector design.According to risk evaluation decision (red-rer-20-09-10-pem-0900 ¿ vhk31000 (dms no.3031203)) justification; ¿¿the risk resulting from the loose connection of tubes is already covered by h2.5.3 / h2.5.4.As well as the information about the warnings and/or precautions to take by h3.1.57.Therefore, no further actions are necessary.Additionally, the ifu provides step-by-step instruction, including attachment and fixation of tube connections (covered with risk id h3.1.22 and risk control id mitigation-055).This is the only complaint recorded in the last 12 months.Therefore, the risk is adequately covered and sufficiently mitigated by the existing risk controls.¿¿.Based on the red-rer-20-09-10-pem-0900 decision, no further action is needed.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.H3 other text : the product was discarded by the customer.

• Brand Name: VENOUS HARDSHELL CARDIOTOMY RESERVOIR
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• MDR Report Key: 10418849
• MDR Text Key: 204071740
• Report Number: 8010762-2020-00259
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: VHK RESERVOIR
• Device Catalogue Number: 701049185
• Device Lot Number: 92268315
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1