MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SCP WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 48-40-00

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in united states.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report of a defective arterial clamp during set up.There was no patient involvement.

Manufacturer Narrative

A livanova field service engeneer was dispatched to the customer site and cp drive, erc and wheel replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: through follow-up communication with livanova field service representative, it was learned that cp5 drive was replaced since it was damaged from misuse, the plastic part that holds the disposable was cracked/broken.Also the wheel was replaced since it was broken.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

Based on all collected information and taking into account similar complaints, the root cause of the reported issue could be traced back to: mechanical fault (blocked clamp spindle #60-05-13).Defective hall sensors located in the erc stator #97-103-645.A defective zka #90-305-310 or zkb #90-305-320 board.Based on the above, an isolated early failure of the aforementioned components cannot be ruled out as the root cause of the reported error message.No specific action was currently deemed necessary.

• Brand Name: SCP WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16960610
• MDR Text Key: 315538340
• Report Number: 9611109-2023-00227
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901068
• UDI-Public: (01)04033817901068(11)220809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Device Catalogue Number: 60-05-65
• Device Lot Number: 60S24024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 05/15/2023; 06/14/2023; 08/10/2023
• Supplement Dates FDA Received: 06/13/2023; 07/11/2023; 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1