MAUDE Adverse Event Report: HAEMONETICS CORP. RTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

Catalog Number 1050-110-ENG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Blood Loss (2597)

Event Date 12/23/2013

Event Type  Injury  

Event Description

Haemonetics received a report on (b)(6) 2013 from a customer reporting a pt that went into renal failure post-op.The orthopat device was utilized during the surgical procedure.The customer reported that a (b)(6) year old male underwent spinal surgery.The pt diagnosis was t-10 to s-2 extension of fusion the orthopat device, serial number unk, was utilized during the procedure and it ran on auto mode.There were no reported issues, error messages or anything out of the normal operation during the surgery.There were also no pt events recorded.The pt had no problems during the procedure in regards to urine output (850ml in operating room), or recovery (350ml).An issue was noticed during the following 14 hours of patient observation.The pt had a total of 121ml of urine output.After confirmation through lab tests and a renal ultrasound and a regimen of drugs, the patient was diagnosed with acute kidney injury with oliguria.The pt was then transferred to a higher level of care and placed on dialysis.Haemonetics does not have any other report to date that links the orthopat device to renal failure.The pt had a volume of 1585ml of autologous blood washed; 700ml of autologous blood transfused and 1 unit of packed rbcs (allogeneic) transfused.The total estimated blood loss was 2365ml.The pre-op lab values, listed, suggest the renal function was outside the normal limited prior to surgery.This pt had many underlying medical issues and a large volume of blood loss associated with this surgical procedure.There is no evidence presented which indicates that the orthopat malfunctioned.It is presumed that the wash cycle performed as expected and did not contribute to the report of renal failure.

Manufacturer Narrative

The customer does not have the serial number of the device used in this surgical procedure recorded, therefore, the device has not been returned.(b)(4).

• Brand Name: RTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM
• Manufacturer (Section D): HAEMONETICS CORP.; 400 wood rd.; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd.; braintree, MA 02184 ; 7814367209
• MDR Report Key: 3595407
• MDR Text Key: 4094088
• Report Number: 1219343-2014-00002
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2013

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1050-110-ENG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 118