MAUDE Adverse Event Report: CONCORD MANUFACTURING CRIT-LINE III BLOODCHAMBER II; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 191058

Device Problem Fluid/Blood Leak (1250)

Patient Problems Rash (2033); Blood Loss (2597)

Event Date 10/21/2017

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal association with the crit-line blood chamber and the reported blood leak exists.Although the blood loss was minor with < 3 ml blood loss and the patient was able to complete the scheduled 120 minute hemodialysis (hd) treatment, the leak and open circuit resulted in the need for prophylactic medication (vancomycin and ciprofloxacin) being administered.At which time, the patient demonstrated an adverse reaction (red man syndrome) to the vancomycin requiring the medical intervention of benadryl and tylenol.The probability of the crit-line leak contributing to need for prophylactic antibiotic treatment with the resulting red man syndrome exists.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

It was reported that a (b)(6) white, female, end stage renal disease (esrd) stage 4 patient had been utilizing hemodialysis (hd) therapy three times per week since (b)(6) 2017 for pre-transplant treatment.The patient was scheduled to have transplant during the upcoming week.Approximately 5 minutes into the hd treatment on (b)(6) 2017 during a scheduled 120-minute hd treatment via catheter lines running arterial-arterial and venous-venous, the registered nurse (rn) noticed a small blood leak in circuit where the crit-line blood chamber and arterial line (medisystems hemodialysis blood tubing) meet.The leak was not alleviated by tightening of the connection.The blood chamber was removed from circuit and the blood line was attached directly to dialyzer with no further leaking noted.The estimated blood loss was reportedly less than 3ml and there was no change in the patient status.The patient completed her 120 minutes of scheduled hd treatment.However, per facility policy of the reported open circuit, blood cultures were drawn and empiric vancomycin 200 mg intravenous (iv) one time and ciprofloxacin 250 mg via gastrointestinal tube (g-tube) (for 3 days), was administered post hd treatment.Toward the end of the vancomycin infusion (after about 55 minutes), the patient developed reddening around the face and ears and appeared to be itching.The infusion was discontinued.It was determined that the patient had developed red man syndrome reaction from the vancomycin, at which time benadryl and tylenol were administered via g-tube with excellent response.The patient remained hemodynamically stable though out hd treatment and during red man syndrome.The patient completed the next scheduled hd treatment without any reported issues.There was no observed crack or defect with the blood chamber or blood line products and no observed packaging damage.The blood chamber and one unused companion sample are available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Follow-up #3: device evaluation: a follow-up product investigation report was received by medica.The complaint sample was received at medica for physical evaluation.The returned sample did not show any kind of leakage.The investigation into the cause of the reported problem was not able to confirm the reported leak.Therefore, the complaint is not confirmed.The original investigation conclusion stands as concord plant also tested the sample and the testing could not reveal a probable cause for the customer complaint.Should additional information become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Follow-up #2: device evaluation: a follow-up product investigation report was received by medica.The batch record analysis found no deviation in the production and quality control processes.A review of production process and quality control (qc) inspections on the bloodchamber part number 191058 was conducted by the manufacturer.All parts are inspected and processed according to approved procedures and dedicated control cards including visual, dimensional, functional, and packaging controls.Molded parts are inspected and released by the by the manufacturer based on qc operating instruction.The assembling of the parts is performed through validated automatic assembly equipment, which is subject to periodic maintenance.There are controls in place to confirm the assembling process, including verification of correct bonding between body and dialyzer connector, flow control, leak test, dimensional inspections, presence and correct screwing of the caps on the twist-lock connector and dialyzer connector, and releasing station.All non-conforming units are isolated for scrap destruction.The packaging activities are in compliance with approved operation instruction, including visual and dimensional inspections.Based on medica's review of the manufacturing and inspection of the product, there is no detection of any deviation which could confirm the complaint event.As the complaint sample has not yet been made available to be inspected by medica, the complaint cannot be confirmed and a root cause is not able to be determined.The original investigation conclusion stands.Should additional information become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device evaluation: the sample was returned to the concord manufacturing plant for evaluation.A visual inspection of the sample confirmed it was in good cosmetic condition and revealed no defects.The sample was subjected to a water pressure test.The returned sample was connected to test tubing and pressurized with water.The sample properly connected to the tubing and did not leak when water pressure was applied.The concord plant confirmed that the lot met all specifications for release.The batch record analysis performed by medica confirmed that no anomalies were recorded during production or quality control processes.The investigation into the cause of the reported problem was not able to confirm the reported leak.The testing of the returned sample could not reveal a probable cause for the customer complaint.Therefore, the complaint is not confirmed.

• Brand Name: CRIT-LINE III BLOODCHAMBER II
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7071864
• MDR Text Key: 93367799
• Report Number: 2937457-2017-01271
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861102020
• UDI-Public: 00840861102020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160749
• 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,Followup,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 191058
• Device Lot Number: 16071307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 2008K MACHINE; FRESENIUS F40 DIALYZER; MEDISYSTEMS BLOOD TUBING
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 13