MAUDE Adverse Event Report: FRESENIUS USA, INC. CRIT-LINE III BLOOD CHAMBER II; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number 191058

Device Problem Leak/Splash (1354)

Patient Problems Erythema (1840); Blood Loss (2597)

Event Date 10/21/2017

Event Type  malfunction  

Event Description

Hemodialysis was initiated via catheter lines running a-a/v-v with good flow noted.Approximately 5 minutes into treatment the rn noticed a small blood leak in circuit where crit line connecting piece and arterial line meet.The leak was not alleviated by tightening of the connection.Connection piece removed from circuit and blood line attached directly to dialyzer with no further leaking noted.Because of the open circuit per policy blood cultures were drawn and empiric vancomycin and ciprofloxacin were provided.Toward the end of the vancomycin infusion the patient developed reddening around the face and ears without swelling or shortness of breath.The patient remained hemodynamically stable.The patient received benadryl and tylenol for presumed re man syndrome reaction with excellent response.Ciprofloxacin was administered for total of 3 days.Blood cultures were negative.The patient returned for hemodialysis and remained afebrile.

Event Description

Hemodialysis was initiated via catheter lines running a-a/v-v with good flow noted.Approximately 5 minutes into treatment the rn noticed a small blood leak in circuit where crit line connecting piece and arterial line meet.The leak was not alleviated by tightening of the connection.Connection piece removed from circuit and blood line attached directly to dialyzer with no further leaking noted.Because of the open circuit per policy blood cultures were drawn and empiric vancomycin and ciproflozacin were provided.Toward the end of the vancomycin infusion the patient developed reddening around the face and ears without swelling or shortness of breath.The patient remained hemodynamically stable.The patient received benadryl and tylenol for presumed re man syndrome reaction with excellent response.Ciproflozacin was administered for total of 3 days.Blood cultures were negative.The patient returned for hemodialysis and remained afebrile.

• Brand Name: CRIT-LINE III BLOOD CHAMBER II
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): FRESENIUS USA, INC.; 4040 nelson ave; concord CA 94520
• MDR Report Key: 6995862
• MDR Text Key: 90860209
• Report Number: 6995862
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2019
• Device Model Number: 191058
• Device Catalogue Number: 191058
• Device Lot Number: 16071307
• Other Device ID Number: CL80020033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PATIENT WAS ON HEMODIALYSIS
• Patient Age: 3 YR
• Patient Weight: 13