MAUDE Adverse Event Report: HAEMONETICS CORP. ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

Catalog Number 1050-110-ENG

Device Problem Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/09/2014

Event Type  Injury  

Event Description

Haemonetics received a report on (b)(6) 2014 from the haemonetics cell salvage consultant for an orthopat device with a complaint of "patient hypotensive after receiving 100 ml of orthopat blood." no other information was available.No additional information is known as several attempts were made to reach the customer.No response was received.

Manufacturer Narrative

The device serial number was unknown.The orthopat processing kit was also unknown.Neither were returned to haemonetics for evaluation.No device history record could be reviewed due to no serial number being available.If haemonetics is able to obtain additional information, a supplemental report will be sent.(b)(6).

• Brand Name: ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM
• Manufacturer (Section D): HAEMONETICS CORP.; 400 wood rd.; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd.; p.o. box 9114; braintree, MA 02184 ; 7814367209
• MDR Report Key: 3946478
• MDR Text Key: 4643289
• Report Number: 1219343-2014-00020
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1050-110-ENG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other