MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER 5/5+; APPARATUS, AUTOTRANSFUSION

Catalog Number 00263-00

Device Problems Device Slipped (1584); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 07/31/2015

Event Type  malfunction  

Event Description

Staff attempted to seat the 225-ml bowl into the centrifuge and lock it into place.It was difficult to lock into place so it was removed and reseated again.The latch was still stiff to lock into place, but did lock.Centrifuge was very noisy during operation.A second bowl was used to complete procedure without incident.Manufacturer response for haemonetics cell saver 5/5+ bowl kit-225ml, (per site reporter): manufacturer provided rga# for product return evaluation.

• Brand Name: CELL SAVER 5/5+
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• MDR Report Key: 5187586
• MDR Text Key: 29811909
• Report Number: 5187586
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 00263-00
• Device Lot Number: 1214007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR