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 03-2742-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A hemodialysis (hd) nurse reported during hd treatment a patient had blood on his shirt and under his arm due to a leak noted at the blue venous needle port.Additional follow-up revealed the hd patient was connected to a 2008k2 hd machine and had been dialyzing for approximately an hour and 20 minutes when a blood leak was noted at the blue venous needle port.The patient¿s dialysate flow rate (dfr) was 600 and the patient¿s blood flow rate (bfr) was 400.The rn stated the leak was noted as being an external blood leak at the blue venous needle port where the needle was to be ¿spiked in.¿ the rn stated the port had not yet been used and the exact location of the leak was unknown.Per rn the tubing line was taped to the patient¿s arm, and as such blood came into contact with the patient¿s arm and shirt.No visual damage to the bloodline was observed.The patient¿s estimated blood loss (ebl) was confirmed to be approximately 50ml.The rn stated the treatment was stopped immediately after the blood leak was noted and the patient¿s blood was returned to the patient.Per rn the patient was able to resume hemodialysis treatment the following treatment without further issue.The patient refused to continue hemodialysis treatment and signed an ama (against medical advice) form.The rn stated the patient was able to resume hemodialysis treatment the following session without further issue.The sample was available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Event Description

A hemodialysis (hd) nurse reported during hd treatment a patient had blood on his shirt and under his arm due to a leak noted at the blue venous needle port.Additional follow-up revealed the hd patient was connected to a 2008k2 hd machine and had been dialyzing for approximately an hour and 20 minutes when a blood leak was noted at the blue venous needle port.The patient¿s dialysate flow rate (dfr) was 600 and the patient¿s blood flow rate (bfr) was 400.The rn stated the leak was noted as being an external blood leak at the blue venous needle port where the needle was to be ¿spiked in.¿ the rn stated the port had not yet been used and the exact location of the leak was unknown.Per rn the tubing line was taped to the patient¿s arm, and as such blood came into contact with the patient¿s arm and shirt.No visual damage to the bloodline was observed.The patient¿s estimated blood loss (ebl) was confirmed to be approximately 50ml.The rn stated the treatment was stopped immediately after the blood leak was noted and the patient¿s blood was returned to the patient.Per rn the patient was able to resume hemodialysis treatment the following treatment without further issue.The patient refused to continue hemodialysis treatment and signed an ama (against medical advice) form.The rn stated the patient was able to resume hemodialysis treatment the following session without further issue.The sample was available to be returned for evaluation.

• 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: 7139386
• MDR Text Key: 95801554
• Report Number: 8030665-2017-01143
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 17LR01223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2017
• 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: 54 YR
• Patient Weight: 74