MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Cyanosis (1798); Hypoxia (1918)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that a smiths medical cassette was implicated in under delivery of medical fluid was observed with the pump.A few hours after use, the patient face turned blue and he felt sick.He then recovered and the patient did not require additional medical treatment.There were no other reported adverse events.

Manufacturer Narrative

Other text: relevant patient code added to h6.

Event Description

1/2 reference (b)(4) for all attachments and related complaints) disposable smj#: (b)(4).While using this product for patient, an under delivery of medical fluid was observed in the product.A few hours after use, the patient face turned blue and he felt sick.He then recovered and the patient did not require additional medical treatment.*please put a product photo(s) in the investigation report.*if a product photo(s) provided by smj are uploaded to this complaint, please post it/them on the investigation report wherever possible.

Manufacturer Narrative

Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.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.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11455565
• MDR Text Key: 240956888
• Report Number: 3012307300-2021-01860
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7302-24
• Device Lot Number: 4019429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/10/2021; 05/01/2021
• Supplement Dates FDA Received: 03/11/2021; 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR