MAUDE Adverse Event Report: SORIN GROUP USA, INC. SINAI HS BALTIMORE MD 1; CUSTOM PERFUSION PACK

Catalog Number 084500201

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Death (1802)

Event Date 09/10/2014

Event Type  Death  

Event Description

Sorin group received a report that the venous line tubing from the sorin custom perfusion pack disconnected from the connector of the venous cannula.Blood loss 500cc.Blood was transfused during the case.The facility did not communicate if the transfusion was due to the tubing coming off the cannula.The facility also stated the pt expired, but did not indicate if the reported incident was related to the death.

Manufacturer Narrative

The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that the venous line tubing from the sorin custom perfusion pack disconnected from the connector of the venous cannula.Blood loss 500cc.Blood was transfused during the case.The facility did not communicate if the transfusion was due to the tubing coming off the cannula.The facility also stated the patient expired but did not indicate if the reported incident was related to the death.The product was not returned for evaluation.Additional communication with the customer confirmed that the cannula and connector were not sorin group products, and that only the tubing was from the sorin custom perfusion pack.During the follow-up communication, the customer also indicated that the issue was caused by wear and tear of the connector and that the patient death was not associated with this event.Because the product was not returned for evaluation, the failure was not reproduced.Without the ability to reproduce the reported issue, the root cause could not be determined and no corrective actions could be identified.A review of the dhr was unable to identify any concessions, deviations or non-conformities relevant to the reported failure.No product defect or trend for this type of issue has been identified at this time.

Manufacturer Narrative

During a review conducted on august 24, 2016, it was discovered that the initial report, filed in october 2014, indicated "other: see below" in the "type of reportable event" field.This should have been marked as "death.".

• Brand Name: SINAI HS BALTIMORE MD 1
• Type of Device: CUSTOM PERFUSION PACK
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4194051
• MDR Text Key: 17996343
• Report Number: 1718850-2014-00366
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 084500201
• Device Lot Number: 1306000026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 94