MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; ETHOX 4010H INFU-SURG, 1000ML PRESSURE INFUSER BAG AP

Model Number	950194310
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pressure bag insufficient function would delay the patient from receiving therapy.This is attached to an arterial line and can impact patient therapy in emergency situations.
Event or Problem Description
The use of this type of pressure bag is not sufficiently effective in emergency situation. .
Event or Problem Description
The use of this type of pressure bag is not sufficiently effective in emergency situation. .
Additional Manufacturer Narrative
The pressure bag insufficient function would delay the patient from receiving therapy.This is attached to an arterial line and can impact patient therapy in emergency situations.Risk assessment performed with rma-20012c, ethox pressure infusion bag, product risk analysis.The complaint most aligns with risk id r10, "long-term use degrades or fatigues the pressure infusor assembly" with the hazard of "pressure loss during infusion procedure", with a severity rating of 7/10 (extreme).Given that there were no complaints about this issue for part 950194310 in the 24 months preceding the complaint reporting date, the occurrence rating is 'improbable'.Per table 1a in ref-20001-c1, extreme severity (7/10) by improbable indicates that a 'low risk' with 'capa optional'.Reviewed table 2a in ref-20001-c1, and none of the incidents described apply to this complaint.Complaint not confirmed as the returned product was conforming.The supplier was notified of the customer complaint on 11/9/23.Complaint history review was performed and there were no complaints for this issue.A dhr review is not possible as this part is purchased as a finished good from a supplier.Sent a follow up to the customer.After receiving additional information, another follow up was sent.Risk assessment performed and determined the complaint is low risk.

• Brand Name: SUNMED LLC
• Common Device Name: ETHOX 4010H INFU-SURG, 1000ML PRESSURE INFUSER BAG AP
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17890131
• Report Number: 1314417-2023-00021
• Device Sequence Number: 7551906
• Product Code: KZD
• UDI-Device Identifier: 20889483151867
• UDI-Public: 20889483151867
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: 950194310
• Device Catalogue Number: 950194310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown