MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA PUMP; PUMP, INFUSION

Model Number 2111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Respiratory Distress (2045)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that a smiths medical cadd solis hpca pump was involved in a patient incident, resulting in patient harm.There was a depressed level of consciousness with respiratory arrest following initiation of remifentanil pca with background infusion (1.5 mg/kg/h) and single pca dose (0.25 mcg/kg) with the patient's estimated body weight of (b)(6) kg and pca concentration as per msh protocol.There was a code blue call in the hospital with a single cycle of cpr and respiratory support.Iv naloxone 0.8 mg with appropriate clinical response was also provided.The mother recovered without any sequelae, but there was persistent fetal bradycardia following the event with the decision to proceed with an emergency c section.

Manufacturer Narrative

Other, other text: returned device was received in good physical condition.No evidence of reported problem in event log was found.During the evaluation of the device, no faults could be found with the device.The downstream occlusion sensor seal was replaced as a preventative measure.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

Additional information: d10, h3, h10.Additional information was received that the pump did not display any alarms or errors.The clinical staff did not complain that the pump under or over delivered.The pump did not malfunction.

• Brand Name: CADD SOLIS HPCA PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10092290
• MDR Text Key: 192190164
• Report Number: 3012307300-2020-05020
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 2111
• Device Catalogue Number: 21-2111-0300-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/02/2020; 08/17/2020
• Supplement Dates FDA Received: 07/02/2020; 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention