MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SURETRANS; AUTOTRANSFUSION APPARATUS

Catalog Number UNKAA074

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol's mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures.It was reported to davol that during a procedure the suretrans device was place during a knee arthroplasty and within less than 2 hours postoperatively while still in the pacu, the patient's blood began to clot in the drain and collection container.The device was switched to hemovac, with no patient injury reported.The subject product was not returned for evaluation.To ensure proper blood flow during collection and reinfusion, it is advised to routinely check the tubing for patency and make sure that the clamps are open.It was cautioned, that although the system will function without regulated suction, suction regulators (set at -80 to -100 mmhg) are always recommended.At that point it was unclear why the patient's blood clotted in the drain and collection container, root cause was undetermined.Device not returned.

Event Description

It was reported that a suretrans device was placed during a knee arthroplasty.Within <2 hours postoperatively while still in the pacu, the patient's blood began to clot in the drain and collection container.The device was switched to a hemovac.No patient injury was reported due to this event.

• Brand Name: SURETRANS
• Type of Device: AUTOTRANSFUSION APPARATUS
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6741416
• MDR Text Key: 80956227
• Report Number: 1213643-2017-00439
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

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 Catalogue Number: UNKAA074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: .
• Patient Sequence Number: 1
• Patient Age: 53 YR