MAUDE Adverse Event Report: SORIN GROUP USA, INC CARDIOPLEGIA ADAPTERS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number CA-81010

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer has been contacted regarding the device availability.However, the contact did not know if the device is available for return to sorin group usa and forwarded the request to another individual at the facility.It is still unknown if the device is available for return.The investigation is ongoing.A follow-up report will be submitted when the investigation is complete.

Event Description

On (b)(6) 2016, sorin group received a user medwatch report (b)(4) stating that the red taped extension that screws onto cardioplegia adapter caused a high line pressure from the heart lung machine when trying to administer cardioplegia to stop the heart.The cardioplegia system was changed out to a new device from the same lot and cardioplegia was able to flow at an appropriate pressure.This issue caused a delay in the delivery of cardioplegia and the heart was not stopped in the expected time frame.There was no patient injury.

Manufacturer Narrative

The device manufacture date was erroneously left blank in the initial report, submitted november 30, 2016.The device manufacture date is august 2, 2016.

Manufacturer Narrative

Multiple attempts were made to contact the customer via multiple modes of communication to request further information about the event and clarification on product availability.The status of the involved product was never confirmed and no further information has been received regarding the event.The device history record was inspected and no issues or non-conformities were found that would relate to this complaint description.Research determined that there was no available inventory of the reported lot number for examination.As the device was not returned for evaluation, a root cause could not be determined and corrective actions were not identified.However, a capa (b)(4) has been initiated in relation to similar reports.

• Brand Name: CARDIOPLEGIA ADAPTERS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6136995
• MDR Text Key: 61237780
• Report Number: 1718850-2016-00400
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2016

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 Expiration Date: 08/31/2019
• Device Catalogue Number: CA-81010
• Device Lot Number: 1621500043
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/01/2016; 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR