MAUDE Adverse Event Report: HAEMONETICS CORPORATION ORTHOPAT® ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION SYSTEM; APPARATUS, AUTOTRANSFUSION

Model Number 1150H-00

Device Problem Component Missing (2306)

Patient Problem Blood Loss (2597)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2018, haemonetics received a report of an incident in which the customer stated they were unable to return collected blood for autologous transfusion due to a missing component within the orthopat reservoir.The physical reservoirs were not available for evaluation, however the customer provided haemonetics with photographs which captured a missing component within the reservoir.From the provided photographs, haemonetics manufacturing staff were able to identify a missing internal cannula within the reservoir which would directly prevent blood from being drawn out of the reservoir to be washed and processed prior to being transfused to the patient for an autologous transfusion.Based on the photographs provided by the customer, it was estimated that there was approximately 600ml of blood within the reservoir when the issue was discovered.Haemonetics has reached out to the customer for additional information regarding the patient's condition and outcome as a result of this incident, the hospital staff responded stating that the patient had an estimated blood loss of 450ml, and did not require an allogenic transfusion, there was no report of any significant complication or injury to the patient.Haemonetics is addressing this issue by means of a voluntary product recall, an urgent medical device recall was issued on july 13 2018 to notify all customers utilizing this product of a possible manufacturing deficiency and to replace all impacted product in the field with suitable replacements.

Event Description

On (b)(4) 2018 haemonetics received a report of an incident in which the customer was unable to return blood to a patient after collecting salvaged blood in the orthopat reservoir.Based on information provided by the hospital, the patient was undergoing surgery to correct a broken femur.Based upon photographs provided, it is estimated that approximately 600ml of salvaged blood was within the reservoir.Upon inspection, the customer identified that there was a missing cannula component within the reservoir.The missing cannula was preventing the collected blood from being drawn out of the reservoir to be washed and transfused back to the patient.Follow up with the hospital indicated that the patient did not require an allogenic blood transfusion, hospital staff estimated the total blood loss to be approximately 450ml.

• Brand Name: ORTHOPAT® ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184 ; 7813487327
• MDR Report Key: 7699540
• MDR Text Key: 114676692
• Report Number: 1219343-2018-00019
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747017145
• UDI-Public: (01)10812747017145(17)201017(10)1017050
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K962475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2020
• Device Model Number: 1150H-00
• Device Lot Number: 1017050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other