MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 98 MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955403

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2023

Event Type  malfunction  

Event Description

It was reported that during treatment with an ak 98 machine, an excessive heparin delivery to patient was observed.The setting for the continuous infusion rate was 2 ml/hour.The total accumulative heparin volume was 11.2ml instead of 7.2 ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation along with photographs of the device.Visual inspection of the actual device did not identify any abnormalities that could have contributed to the reported condition.During visual inspection of the provided photographic samples, were of the heparin menu indicating the heparin infusion set of 2 ml/h and the prestop value of 30 min.The 2nd and 3rd photos refer to the treatment overview page: it can be observed that at 14:12 the infused heparin volume was 3 ml, and at 14:42 it was 8.2 ml.Per the event history log review: a first bolus of 2 ml was booked (at 13:21) during priming, automatically delivered at the beginning of treatment (at 13:37).At the end of the bolus (at 13:39), the heparin delivery continued because the continuous infusion (2 ml/h) was active.At 14:34 the accumulated heparin was 3.8 ml (2 ml bolus + 1.8 ml due to continuous delivery) and a second bolus of 4.3 ml was selected by operator.Therefore, at 14:42 the accumulated volume of heparin was 8.2 ml (2 ml due to first bolus + 1.9 of continuous infusion + 4.3 due to second bolus).At 14:42, at the end of the second bolus, the continuous delivery started again.No other bolus was infused, and the treatment continued correctly with the delivery of 2 ml/hour of heparin as set by the operator.At 16:12 the amount of heparin delivered was 11.2 ml.The heparin delivery was stopped at 16:19.The device was evaluated on-site by a non-baxter technician.The heparin pump was replaced.No further information was received by the technician.The reported condition was not verified.However, it cannot be ruled out that the second bolus was requested by mistake, and the claimed incorrect heparin delivery was then due to an error in setting the machine up.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 98 MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16652758
• MDR Text Key: 312505241
• Report Number: 9616026-2023-00023
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HEPARIN