MAUDE Adverse Event Report: HAEMONETICS ASPIRATION/ANTICOAGULATION SET

Catalog Number 208

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

During a procedure using a cell saver, an unknown foreign substance (resembling human tissue) was identified in the supply tubing from the heparin / saline bag.

• Brand Name: ASPIRATION/ANTICOAGULATION SET
• Type of Device: ASPIRATION/ANTICOAGULATION SET
• Manufacturer (Section D): HAEMONETICS; braintree MA 02184
• MDR Report Key: 3748440
• MDR Text Key: 21311740
• Report Number: MW5035593
• Device Sequence Number: 1
• Product Code: CAC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2014

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: 10/31/2018
• Device Catalogue Number: 208
• Device Lot Number: 13103041
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEPARIN IN SALINE
• Patient Age: 70 YR
• Patient Weight: 68