MAUDE Adverse Event Report: NULL; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Device Alarm System (1012)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 05/29/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the device was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Device information are unknown.Operator of device is patient/consumer.

Event Description

It was reported that a spontaneous, remunity remote has had an occlusion alarm.There were no kinks in the tubing.The patient last changed infusion site two days ago.It was recommended that the patient change the site due to timing.The patient had trouble breathing with oxygen saturation lower than normal.It was recommended that the patient use oxygen as well as previous instruction of changing infusion site.The dose or amount: 39.76 ng/kg/min.The patient was able to switch to backup product with infusion continuing.The infusion is life-sustaining.

Manufacturer Narrative

Additional information received via email from customer on 27-jun-2022 and attached by icu medical in complaint: patient details updated in attributes.No product are available for return.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updates not required.H4: device manufacture date could not be completed due to lack of information regarding lot number.H10: device evaluation: the device was not returned for investigation, so no visual inspection and functional test were performed.Because no product was returned, the investigator was unable to confirm the reported complaint.If the product is returned however, the manufacture will reopen this complaint for further investigation.No lot number was provided; therefore, device history record review could not be completed., corrected data: d2: correction: product code: fpa.D2: correction: common device name: set, administration, intravascular.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 14878502
• MDR Text Key: 297639021
• Report Number: 3012307300-2022-12773
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female