MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP SAPPHIRE + PBKSET 2CLV; ADMINISTRATION SET

Model Number	1638502
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is available for investigation.
Event or Problem Description
The event involved a customer allegation of a patient scheduled to receive dextrose 10% with electrolytes at 18mm, but went a little over 200mm via sapphire primary piggyback set 2 clave y-site, 120 inch on (b)(6) 2018.Dextrose 10% with electrolytes was discontinued, a pediatric endocrinologist was consulted and iv regular insulin 0.15 units/kg was given stat to treat a glucose of 1834.The patient¿s glucose decreased to 534 and another dose of regular insulin 0.15 units/kg was given stat.After 30 minutes, the glucose decreased to 314.The patient was transferred to the regional pediatric hospital for further endocrine assessment.It was mentioned that the priming method used was with the pump and approximately 20 ml of volume was used for priming.Initially, the volume of the bag was 515 ml and approximately 375 ml was left in the bag with a vtbi difference of 140 ml.The pump was placed in a cradle accessory during the treatment.It was also reported that the pump did not alarm at the beginning, during, or the end of the treatment.It was also reported that the pump never alarmed.The nurses checked the pump with 6 seconds left when pump was stopped.The pump read that 17.6 ml infused over the last 2 hours.
Additional Manufacturer Narrative
A sister sample based on the list number reported was received for analysis and investigation from the distribution center.A visual inspection of the sample did not reveal any visual defective condition.The sample was reviewed under ultraviolet light and all the sealer points showed presence of solvent, the sample was primed with the pump according to the label instructions with sterile water and was primed correctly.The sample was tested using a sapphire pump and passed the test, no leaks or occlusions were noted.The sample does not confirm the experience code.No probable cause was found since the reported event was not duplicated during the testing; therefore, the complaint was not confirmed for further analysis and investigation, a batch record review was performed on the lot impacted; as a result, no discrepancies that may have contributed to a complaint of this nature were found.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the final visual, physical evaluation results indicated that the product met specification requirements.Contact information has been updated.

• Brand Name: NDEHP SAPPHIRE + PBKSET 2CLV
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8226471
• Report Number: 9615050-2019-00001
• Device Sequence Number: 19360932
• Product Code: MRZ
• UDI-Device Identifier: 10887787006503
• UDI-Public: (01)10887787006503(17)210601(10)905025H
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 1638502
• Device Catalogue Number: 163850455
• Device Lot Number: 905025H
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 05/19/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRAUN INTROCAN SAFETY IV CATHETER,24 GUAGE 3/4INCH; SAPPHIREPLUS INFUSION PUMP; BRAUN INTROCAN SAFETY IV CATHETER,24 GUAGE 3/4INCH; SAPPHIREPLUS INFUSION PUMP