MAUDE Adverse Event Report: FRESENIUS KABI DEUTSCHLAND GMBH INFUSION SET VL ON 90; INFUSION PUMP SYSTEM

Catalog Number M46444900S

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  Injury  

Event Description

Per customer: "failure on the tubing of chemotherapy : ifosfamide (holoxan).During the application of the preparation, the nurse notices air bubbles in the tubing, the syringe pump alerts.Attempt to purge the tubing was ineffective.Help from a colleague who, while manipulating the bag, notices that the tubing is disconnected from the bag.Cytotoxic liquid splashes onto the nurse's face and the 2nd nurse's hands.The event occurs for the 1st time.This led to a disorganization of the service and unscheduled examinations and medical acts.Immediate measures were taken: the 2 nurses proceeded immediately to rinse the areas affected by the chemotherapy product projection.The doctor was notified.The pharmacist was notified and gave safety instructions for the agents and the process to follow for the chemotherapy bag.The administration to the patient was postponed until the following day.The bag was set aside.Declaration of work accident for the 2 nurses." additional information is needed to perform the investigation.No adverse effects to the caregivers (for the splashing of the cytotoxic liquids) nor the patient (delay of therapy for 24 hours) have been communicated; this is being reported as a conservative measure as we await additional information.

Event Description

1.Reported complaint spike disconnecting from bag 2.Quantity and condition of sample(s) we did not receive any sample or picture for investigation 3.Concerned product code / batch infusion set vl on 90/ m46444900s/ 32051651 4.Investigation report we did not receive any samples or pictures for investigation, therefore we are not able to confirm if complaint reason is related to the production process or material fault.Based on the complaint reason, we checked visually all retain samples and we do not see any defect.We have conducted a free flow and tightness test and we do not find any irregularities.In the next step, we performed a practical test on the pump and the results was correct, during the test we did not observe any air in the system, and the spike did not disconnect of the bag.In addition, we performed a tensil test and there were no abnormalities.Batch documentation did not show any deviation related to the complaint reason.During the last 12 months (time period 30.05.2022 to 29.05.2023) we did receive any similar complaints for this article m46444900s.This is the first compleint related to this batch 32051651 for the same defect.5.Root cause not determined, as no defects have been found during investigation performed on the retain samples.Further no irregularities detected during review of production documentation.Without the affected sample a more detailed investigation is unfortunately not possible.6.Corrective action.Corrective and preventive actions are not necessary as the complaint reason is not reproducible for us.7.Conclusion based on these results we cannot confirm this complaint.Please note that it is very important for us to receive the affected sample to perform an adequate root cause analysis.

• Brand Name: INFUSION SET VL ON 90
• Type of Device: INFUSION PUMP SYSTEM
• Manufacturer (Section D): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• MDR Report Key: 16841234
• MDR Text Key: 314268371
• Report Number: 3004548776-2023-00133
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M46444900S
• Device Lot Number: 32051651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2023
• Distributor Facility Aware Date: 03/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other