MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD¿ MEDICATION CASSETTE WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7302-24

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Mfr# clarification: new registration number (b)(6), ((b)(6)) is now being used for mfr report number, replacing registration number (b)(6), ((b)(6)).

Event Description

It was reported that a cadd" medication cassette with flow stop was involved in an oxynorm overinfusion incident.The infusion was run for three hours and it was observed that 25ml was already infused into the patient for only one bolus.The programmed continuous flow rate was 4mg/ml.Troubleshooting involved testing the infusion system without patient involvement and showed that the system infused 3 times more than the programmed volume.The infusion system was tested with different cassettes and it was noted that the problem stopped.The cassette involved in the incident was retested without patient involvement and the observed incident did not occur again.Intravenous narcan was administered to decrease the oxynorm overinfusion effects.No permanent injury was reported.See mfr: 3012307300-2016-00362.

Event Description

It was further reported that the device was in use starting on (b)(6) 2016 and the reported event was observed on (b)(6) 2016.Additionally it was reported that the device was programmed at a rate of 0.1 ml/h with an allowed bolus rate of 0.25ml.

• Brand Name: CADD¿ MEDICATION CASSETTE WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6103285
• MDR Text Key: 59918837
• Report Number: 3012307300-2016-00363
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CADD-LEGACY® PCA PUMP
• Patient Outcome(s): Required Intervention