MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A user facility reported that a blood leak occurred approximately 1 ½ hours after initiation of the patient's hemodialysis (hd) treatment.The blood leak was noted as being a bloodline tubing leak.The machine did not alarm as it is not intended to do so.Blood was visually observed leaking externally from the red connection piece of the arterial tubing.No damage to the bloodline tubing was visible.Additionally, no damage to the bloodline packaging was observed.The patient¿s estimated blood loss (ebl) was noted as being approximately 300 cubic centimeters (cc).No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient completed treatment with a new set-up on the same machine.The complaint device was available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.A visual examination of the returned device found that a gap was present between the main line tubing and the pump ¿t¿ connector; no other issues were detected on the tubing set.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or any associated rework during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot passed all release criteria.The investigation into the cause of the reported problem was able to confirm the failure mode.A visual examination found that a gap was present between the main line tubing and the pump ¿t¿ connector due to mis-assembled tubing.Therefore, the complaint has been deemed confirmed.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6602795
• MDR Text Key: 76406667
• Report Number: 8030665-2017-00287
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 16SR01158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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: 59 YR
• Patient Weight: 99