MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Title collection of peripheral blood stem cells from a (b)(6)-old girl with the use of combined heparin and citrate anticoa gulation source journal of clinical apheresis, volume 28, 2013 (309¿310) date of publication: 24 july 2013.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to literature source of study performed 2013, on a previously healthy girl ((b)(6)) who was diagnosed with stage iv neuroblastoma, a double lumen catheter was placed in the right femoral vein.The plan was to perform apheresis and process a total of four bvs (blood volumes), amounting to 2,100 ml of blood, but, unfortunately, the line stopped working shortly after the start of the procedure despite serial flushing with ns 0.9%.One mg of alteplase infusion in each lumen was partially successful in restoring the blood flow, and it was possible to process 1.3 bvs.The following day the line was changed over a guide wire.There was no reporter patient outcome.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8537901
• MDR Text Key: 142785778
• Report Number: 3009211636-2019-00100
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2019

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: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 04/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 7