MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problems Fluid/Blood Leak (1250); Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon final review of medical records by post market clinical staff and completion of the plant's investigation.

Event Description

An inpatient user facility reported a blood leak two and a half hours into a patient treatment.The medication line had been clamped and knotted as the patient was not scheduled to receive heparin.The medication port began to drip blood, which resulted in a nurse identifying a blood leak.The clamp was readjusted to it's proper position, and the leak stopped.The patient then continued treatment and was able to complete therapy successfully.The patient experienced a slight loss in blood pressure.No other adverse symptoms or patient harm occurred.The patient was given a 200ml bolus of normal saline to increase blood pressure.The estimated blood loss was 150cc.Blood lines are not available as they were discarded by the facility.

Manufacturer Narrative

No product is available from this lot on distribution centers to be analyzed.The entire lot has been sold and distributed.The actual device was not evaluated by fresenius personnel therefore the failure mode cannot be confirmed or replicated in field testing.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.Medical records were provided and have been reviewed by a post market clinician staff.Patient is a (b)(6) year old female with esrd on pd therapy who experienced a blood leak during treatment.Based on the 16 pages of medical records information it appears that on (b)(6) 2015, the patient was treated at the dialysis clinic.Patient arrived at the dialysis clinic stating that her dialysis access site had bled the day before and she had a nose bleed that morning.The patient's dialysis started at 06:32.Documents revealed there were no complaints during dialysis and lines were secure.At 9:05 the technician saw there was a blood spill >100ml dripping from the heparin tubing that became unclamped.Patient was asymptomatic.The nurse re-clamped the line and the patient was able to complete treatment without any issues.Patient was administered 200cc normal saline bolus to increase the patient's blood pressure.Patient was able to complete treatment at 10:11.The patient blood work was done and there were no issues discovered.Medical records do not reveal cause of the unclamped tubing.Medical records do not indicate there was a malfunction.Medical records reveal there was no adverse event.

Event Description

Hemodialysis orders: tuesday, thursday, saturday, 3 hours, 30 minutes; 160nre optiflux, bfr 400, dfr autoflow 1.5, edw 70kg, dialysate 3.0k, 2.25 ca, 1.0 mg, 100 dextrose, sodium 137, bicarb machine setting 36, ufr profile type: none, sodium modeling: linear, vascular access: av fistula-standard, additional details: arterial needle size #16g; venous needle size 316g; machine temp 37.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa; reynosa, tamaulipas. cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5229373
• MDR Text Key: 31451725
• Report Number: 8030665-2015-00524
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15KR01365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 72