MAUDE Adverse Event Report: ARTHREX, INC. ANGEL WHOLE BLOOD PROCESSING; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Model Number ANGEL WHOLE BLOOD PROCESSING

Device Problems Break (1069); Fluid/Blood Leak (1250); Failure to Shut Off (2939)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the angel machine continued to spin to try to get blood out of the bag five minutes after it started spinning and the clock stopped.The machine had to be manually turned off and while it stopped turning the abs-10063 angel processing kit broke inside the chamber with blood going all over the chamber.

• Brand Name: ANGEL WHOLE BLOOD PROCESSING
• Type of Device: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 11392984
• MDR Text Key: 234024961
• Report Number: 1220246-2021-02632
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: 00888867083974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK110046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANGEL WHOLE BLOOD PROCESSING
• Device Catalogue Number: ABS-10060
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1