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 03/27/2017

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 immediately 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 a pinhole in the venous chamber of the bloodline.No damage to the bloodline packaging was observed.The patient¿s estimated blood loss (ebl) was noted as being approximately 5cc.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 actual complaint device was returned to the manufacturer for physical evaluation.A visual examination of the returned device found one gate mark (injection mold) on the venous chamber was damaged according to its bill of materials (bom).The complaint investigator was able to observe a pin hole on the gate mark using a microscope.All remaining gate marks of the venous chamber were examined for voids.No voids were present.The device was subjected to a laboratory leak test where the device was submerged in a water bath while pressurized air was forced up to 15 psi for a period of ten minutes into the device.A leak was observed at the gate mark of the venous chamber that was identified during visual examination.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 during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the 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.During visual and microscopic inspection, a pinhole was observed at the venous chamber of the device.Additionally, a leak was identified from the location of the observed pinhole during laboratory leak testing.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: 6516514
• MDR Text Key: 73560231
• Report Number: 8030665-2017-00197
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 16PR01144
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• 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
• Treatment: FRESENIUS OPTIFLUX F160 DIALYZER FINISHED ASSY.
• Patient Age: 81 YR
• Patient Weight: 74