MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2742-9

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

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

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint device was available and returned to the manufacturer for physical evaluation.A visual examination of the returned device found that the taper of the patient connector of the arterial line is bent.Also, the patient end connector was connected to a fistula connector and was observed that the taper of the patient connector does not fit into the end.No damages or excess of solvent was observed on the connector that may be attributed to the bent taper.In addition, a functional test was performed to examine the pressure of the system under water while air is introduced under pressure of 15 psi for a period of ten minutes.During the test air bubbles were noted on the patient end connector as stated in the complaint, and a leak was noted.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.The investigation into the cause of the reported problem was able to confirm the failure mode.A visual evaluation revealed that the patient connector of the arterial line was bent which resulted in the reported leak.Therefore, the complaint has been deemed confirmed.

Event Description

A user facility reported that air was introduced into the system upon initiation of the patient's hemodialysis (hd) treatment.Upon examination of the bloodline, the arterial line luer was noted as not locking/screwing on properly resulting in the observed condition.However, there was no visible damage to the bloodline or luer lock.The machine alarmed for "air detector" and the hemodialysis nurse discontinued the treatment.The defective circuit was removed from the machine and a new circuit was setup on the same machine.The patient was able to successfully complete the hd therapy with no further issues.The patient's estimated blood loss (ebl) was noted as being approximately 250ml.There were no patient adverse effects and no medical intervention was required as a result of this event.The complaint device is available to be returned to the manufacturer for evaluation.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5879021
• MDR Text Key: 53053438
• Report Number: 8030665-2016-00423
• Device Sequence Number: 1
• Product Code: FJK
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 16DR01086
• Other Device ID Number: 00840861100309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2016
• 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: 89 YR
• Patient Weight: 51