MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number 2120

Device Problems No Audible Alarm (1019); Disconnection (1171); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Noise, Audible (3273); Premature Separation (4045)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating that a smiths medical cadd-solis vip ambulatory infusion pump may not have alarmed for occlusion.It was reported that patient was receiving piperacillin and tazobactam through a picc line.It was reported that the picc may have had some occlusion issues.It was reported that it was possible that the patient may have missed a dose.Per reporter, the medication bag was discarded and the missed dose was replaced.No adverse patient effects were reported.

Manufacturer Narrative

Investigation results completed on a smiths medical ventilators|pneupac ventilators vr1 standard.Complaint of rattle in unit was confirmed.When device was shook a rattle was detected, this was isolated to housing stripped and screw loose.Malfunction is believed to be caused by the technician.Device passed all testing.

Event Description

Investigation results completed on ventilators|pneupac ventilators vr1 standard.Summary in h 10.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8899205
• MDR Text Key: 154615415
• Report Number: 3012307300-2019-03872
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586042829
• UDI-Public: 10610586042829
• Combination Product (y/n): N
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0102-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1