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

Model Number 1050-110-JPN

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018, haemonetics was made aware of an orthopat device which was observed to have visible smoke during the power on self test (post).On (b)(6) 2018, a haemonetics field service engineer (fse) evaluated the device and observed that there was a damaged capacitor on the display printed circuit board.The fse reported that the capacitor was the source of the smoke that was observed previously by the device operator, there was no observed evidence of heat/fire damage to the near by components and chassis of the device, the failed capacitor did not result in a device fire.There were no associated injuries reported with this incident, this had occurred prior to a patient being introduced to the system.The device must complete a post prior to a procedure being initiated and a patient being introduced to the system, a failure of the display board will prevent the device from being able to pass the post to protect the patient and device operator from any harms that may result due to hardware failure.The haemonetics fse will replace the failed display pcb and perform any necessary calibrations to ensure the orthopat meets all manufacturer specifications prior to being returned to service.Haemonetics has previously reported instances of thermal decomposition observed within a device, as a result this incident is considered reportable.

Event Description

On (b)(6) 2018 haemonetics was made aware of an orthopat device which had visible smoke observed when the device was powered on.This was observed upon the power on self test (post) protocol, prior to a patient being introduced to the system.There is no patient involvement.The device operator was not harmed as a result of the malfunction observed.

• 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: 8042346
• MDR Text Key: 128211790
• Report Number: 1219343-2018-00047
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/06/2018

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 Model Number: 1050-110-JPN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1