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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR Back to Search Results
Model Number D1000
Device Problem Connection Problem (2900)
Patient Problem Death (1802)
Event Date 07/12/2018
Event Type  Death  
Manufacturer Narrative
The device is not available for return. Samples from the same lot will be returned for investigation. Investigation is not complete.
 
Event Description
The event involved a customer allegation of a death of a patient where blood leaked while a tego connector was in use. The device had been in use for 7 days. The customer reported that the patient was connected to dialysis at 7h50 via a mahurkar catheter implanted in the right jugular vein, unspecified heparin was used during the dialysis session and interdialytic lock solution sodium citrate. The cap had been disinfected with biseptine. It was reported that the arterial and venous lines were switched, the flowrate was too low creating a pa alarm. The site was reportedly protected with a sterile surgical site. Despite the blood lines being switched, it was reported that several pa alarms required the nurses to restart the dialysis. At 8h40 a new pa alarm asserted, in which the nurse found a pool of blood under the bed when going to assess the dialysis machine. At this time, the surgical site was reportedly opened and it was noted that the bed was soaked with blood and that blood had leaked at the junction between the tego connector and the catheter. It was reported that blood loss was more than 100 ml with no volume figure given. The nurse attempted to rescrew the tego connector, perfuse saline to compensate blood loss to the patient, and called the doctor. No other reported intervention was performed. The patient was confirmed deceased by the doctor.
 
Manufacturer Narrative
The actual device involved in this reported event has not been received for testing. The lot number reported by the customer, lot 3349736, does not exist for the list: d1000 tego. Based on the customer's purchasing history, the most likely lot number is 3549736. Icu medical facilitated the return of 5 samples from lot 3549736 from the distributor to further analyze as part of the investigation. (b)(4) samples from lot 3549736 were received from the distributor for testing and investigation. The tego connectors were tested for both pressure and vacuum leakage. All (b)(4) samples met pressure and vacuum leak expectations outlined in the product performance specification. Additionally, the (b)(4) same samples were measured to the iso standard and the male luers were found to be iso compatible. The device history record for lot 3549736 was reviewed and there were no relevant non-conformance's found that would have contributed to the reported complaint. Icu medical has made multiple attempts with the customer to obtain further information to aid in this investigation but have not been successful in obtaining any further information. With respect to the sample involved in this reported event, icu medical has made multiple contacts to the police department; where the suspected device is in possession. We have yet to receive an acknowledgement from the police department. Once the acknowledgement is established, icu medical will appeal for a visitation to the police station for the visual evaluation of involved sample and/or request release of suspected sample to icu medical.
 
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Brand NameTEGO® CONNECTOR
Type of DeviceTEGO® CONNECTOR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
colonia rancho santa clara, ma
ensenada, 22790
MX 22790
Manufacturer (Section G)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
Manufacturer Contact
christopher zanoni
600 n. field drive, bldg h2-2n
lake forest, IL 60045
2247062300
MDR Report Key7742934
MDR Text Key115818464
Report Number9617594-2018-00043
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD1000
Device Catalogue NumberD1000
Device Lot Number3549736
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/02/2018 Patient Sequence Number: 1
Treatment
BAXTER DIALYSIS MACHINE; HEPARIN; INTERDIALYTIC LOCK SOLUTION SODIUM CITRATE; MAHURKAR CATHETER
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