MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. ARISTA AH ABSORBABLE HEMOSTAT; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Catalog Number	SM0007-USA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Renal Failure (2041)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It appears based on the doctor to doctor consult that the patient developed dic (disseminated intravascular coagulopathy), with kidney and respiratory failures.The patient is reported to be stable and improving.Also during the doctor to doctor consultation it was confirmed, there was an error on part of the user of the device as it was used in conjunction with a cell saver (autologous blood salvage) device incorrectly.Based on the information provided this appears to be a use related issue.The ifu addresses the use of arista ah in conjunction with autologous blood salvage circuits.The precaution section of the ifu states "when arista ¿ ah is used in conjunction with autologous blood salvage circuits, carefully follow instruction in the administration section regarding proper filtration and cell washing." the administration section states, "when arista ¿ ah is used in conjunction with autologous blood salvage circuits, a 40¿ cardiotomy reservoir, cell washing and 40¿ transfusion filter, such as a lipiguard¿ or pall filters, must be used." the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Used on patient.
Event or Problem Description
It was reported that during a gynecological procedure to remove cysts fibroids and adhesions, bard arista ah was used in conjunction with an auto transfusion device.The case was completed and the patient was taken to recovery in which after about 15 minutes began to exhibit increased heart rate, hypotension, low urine output and pulmonary edema.The patient was taken to icu where she was stabilized and continues to be on assisted ventilation.The surgeon has requested a doctor to doctor consult.

• Brand Name: ARISTA AH ABSORBABLE HEMOSTAT
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6637382
• Report Number: 1213643-2017-00347
• Device Sequence Number: 16282637
• Product Code: LMG
• UDI-Device Identifier: 00801741044144
• UDI-Public: (01)00801741044144(17)211128
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Catalogue Number: SM0007-USA
• Device Lot Number: 5785401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention