MAUDE Adverse Event Report: CAREFUSION SD 8210 ALARIS SPO2 - MASSIMO; PUMP,INFUSION

Model Number 8210

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer did not authorize or respond to any device repair request.The device was not inspected.No determinations regarding the reported issue nor those requiring escalation were established.The device was returned unrepaired.A review of the device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The device was previously returned for service.The database showed no quality notifications were opened for the device.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.Capa reference: (b)(4).The customer stated that there was no patient involvement.

Event Description

03/02/2018 13:57:35 lauryne wasan (lwasan) npi not confirmed unit received unexpectedly no tracking number found please note: unit is not marked received/prcd until npi is confirmed for repairs and additional information is received/ confirmed by customer 04/04/2018 14:05:37 lauryne wasan (lwasan) unit being returned unrepaired per customer's instruction per phone conversation.James gibbons / 843.777.4103 04/06/2018 08:18:18 annette a mendez (amendez) 1z9791540270380530.

• Brand Name: 8210 ALARIS SPO2 - MASSIMO
• Type of Device: PUMP,INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sriram lakshmanan ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10752794
• MDR Text Key: 228190008
• Report Number: 2016493-2020-27096
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403821011
• UDI-Public: 10885403821011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2018

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: Other
• Device Model Number: 8210
• Device Catalogue Number: 8210
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2006
• 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