MAUDE Adverse Event Report: FRESENIUS KABI DEUTSCHLAND GMBH VOLUMAT LINE; PUMP, INFUSION

Model Number	VL SL00-XP
Medical Device Problem Codes	Break (1069); Connection Problem (2900); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by the customer: customer reported we had an incident today where the spike broke off completely.Also getting reports that the spike is sliding out of the bags.Investigation results: 1.Reported complaint: broken spike.2.Quantity and condition of sample(s): fresenius kabi has received pictures.3.Concerned product code / batch: vl sl00-xp (pvc-free), m77460052, batch: unknown.4.Investigation report: first provided picture presents a part of our fresenius product vl sl00-xp (pvc-free).The product is closed in plastic bag.There are visible a transparent drops of liquid.We see the spike is broken.On the second photo we see the same product, however the whole article is visible in originally closed primary packaging.The spike is not broken on the picture, which suggest that there were no damage before usage.As fresenius kabi did not receive batch number, it is not possible to perform tests on retain sample.Batch documentation overview: as the batch number is unknown, the overview is not possible.In the last 12 months (27.03.2025 to 26.03.2026) fresenius kabi have received only this one complaint for this article m77460052 with the same reason as "broken spike".This is first complaint with this kind of failure for this batch number until now.5.Root cause: the root cause is difficult to determine based only on pictures, however it is visible that in the originally closed packaging the spike was not broken.The product was used; therefore, we cannot exclude handling fault.Probably too much force was used during piercing of spike.The important thing to avoid that failure, is inserting spike into containers direct in an axial direction.Fresenius kabi did not know what kind of bag of medication was used and this also could have impact for inserting the spike.6.Corrective action: preventive and corrective actions are not necessary, as fresenius kabi assumes this complaint to be probably a handling fault.7.Conclusion: based on these results fresenius kabi cannot confirm the complaint reason.

• Brand Name: VOLUMAT LINE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• Manufacturer (Section G): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047
• MDR Report Key: 24841835
• Report Number: 9681819-2026-00019
• Device Sequence Number: 9873992
• Product Code: FRN
• UDI-Device Identifier: 04250273733884
• UDI-Public: 04250273733884
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: VL SL00-XP
• Device Catalogue Number: M77460052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/10/2026
• 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
• Patient Sex: Unknown