MAUDE Adverse Event Report: SORIN GROUP USA, INC. UNIV OF VA CHARLOTTESVILLE, VA 1; CUSTOM PERFUSION PACK

Catalog Number 047000100

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2015

Event Type  Other  

Event Description

Sorin group received a report that the tubing fell out of the arterial filter purge line luer and sprayed blood on the clinician.The product has been used for 5 days prior to the incident.No pt injury was reported and no blood was given to the pt to compensate for the sprayed blood.

Manufacturer Narrative

Sorin group received a report that the tubing fell out of the arterial filter purge line luer and sprayed blood on the clinician.The product had been used for 5 days prior to the incident.No pt injury was reported and no blood was given to the pt to compensate for the sprayed blood.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that the tubing fell out of the arterial filter purge line luer and sprayed blood on the clinician.The product had been used for 5 days prior to the incident.No patient injury was reported and no blood was given to the patient to compensate for the sprayed blood.Both an unused arterial filter purge line and the male luer fitting under complaint were returned to sorin group usa for evaluation.The mated tubing from the involved unit was not returned.Inspection of the returned devices under ultra violet light found that there was less solvent present on the involved male luer than on the unused unit.The lot number of the involved pack was not provided.Without a lot number the specific individual(s) responsible for this part of the assembly could not be identified.Therefore, a manufacturing awareness was issued to notify all production employees about the issue and heighten awareness to proper bonding technique.Without the lot number, the device history record could not be identified for review and the lot number for the involved tubing could not be identified so no review of receiving records or retain parts could be performed.No trends related to this issue have been identified.The reported issue occurred after 5 days of continuous use so the connection lasted well past the rated six hours of continuous use for this product.The sorin heart/lung perfusion pack instructions for use indicate, "this heart/lung perfusion pack is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours." and "it is not designed for long-term use (greater than six hours)".Based on the information summarized above, no further actions are deemed necessary at this time.

• Brand Name: UNIV OF VA CHARLOTTESVILLE, VA 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: 4818938
• MDR Text Key: 5899065
• Report Number: 1718850-2015-00170
• Device Sequence Number: 1
• Product Code: PIN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 047000100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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