MAUDE Adverse Event Report: FRESENIUS KABI DEUTSCHLAND GMBH INFUSION SET VL ST 00; INFUSION PUMP SYSTEM

Catalog Number M46445860

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problems Hypersensitivity/Allergic reaction (1907); Insufficient Information (4580)

Event Date 12/02/2021

Event Type  Injury  

Event Description

Per customer: "patient experienced infusion related reaction during line prime.For reactive drugs we have the line prime set at 500 ml per hour for 20 ml.This should be adequate volume to bring the drug down to the patient but not actually administered into the patient.Our fk primary lines have priming volumes of 27 ml vl pr72-11 and 25 ml vl pr42-12 for the entire tubing.Our secondary med lines (icu medical) have priming volumes of 7 ml.Factoring in that the secondary med set is connected to the highest port and thus some volume is lost, both lines were tested and the vl pr42-12 primes with approximately 18 ml and the vl pr42-11 (micron filter) primes with exactly 20 ml.You would then need to add the secondary med line volume to both of these for total priming volumes of 25 ml and 27 ml.The patient reacted on the 27 ml line when the line prime was infusing at 500 ml for 20 ml.The drug should not have reached the patient during this time.We are now re configuring our prime volume to 15 ml.Overinfusion, hypersensitivity , allergic reaction, overdose and serious injury illness impairment" no other information was provided by the customer regarding the event or the patient.1.Reported complaint problems with flow rate 2.Quantity of the sample(s) we did receive any complaint sample or photos for investigation.3.Concerned product code/batch vl pr 72-11 (m46445860)/ unknown batch number 4.Investigation report we did not receive any complaint sample or photos for investigation.Additionally no batch number of complaint product was provided.As the batch number is unknown it is not possible to perform retain samples inspection and review of the batch documentation.This is the first complaint that we received during the last 12 months (01.Sep.2021- 26.Sep.2022) related to this failure (problems with flow rate) for this article (vl pr 72-11 (m46445860)).5.Root cause the root cause of this failure is not determined as we did not receive any complaint sample or photo for investigation.In addition no batch number was provided.6.Corrective action corrective and preventive actions are not necessary as the root cause of failure is not determined.7.Conclusion based on the above results we cannot confirm this complaint.Please note that without complaint sample or photo picturing a defect and without batch number we are not able to perform detailed investigation and adequate root cause analysis.

• Brand Name: INFUSION SET VL ST 00
• 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: 15540952
• MDR Text Key: 301156384
• Report Number: 3004548776-2022-00201
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M46445860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2022
• Distributor Facility Aware Date: 09/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other